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Boston Scientific Corporation FDA Recalls

381 recalls on file across devices, 124 of them Class I and 374 still open. Matched by name to BSX.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; Class IAug 24, 2026Tip may fracture or detach, leading to device fragments rema
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All VeClass IIAug 6, 2026There is potential for a delay in AF Burden Alert notificati
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All VerClass IIAug 6, 2026There is potential for a delay in AF Burden Alert notificati
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All VerClass IIAug 6, 2026There is potential for a delay in AF Burden Alert notificati
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1Class IIJul 22, 2026A subset of power adapters used with the connect console may
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Class IIJul 14, 2026Device may fail to deploy the cinch implant and/or fail to c
Suture Cinch Long 1pk. Endoscopic tissue approximation device.Class IIJul 14, 2026Device may fail to deploy the cinch implant and/or fail to c
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheterClass IJul 9, 2026Potential for arterial sheath tip separation or partial tip
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheterClass IJul 9, 2026Potential for arterial sheath tip separation or partial tip
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Class IIJun 30, 2026Potential for breach in sterile barrier of device packaging.
Rapid Refill Continuous Injection System, UPN M00566001Class IIJun 30, 2026Devices contain recalled Medline Namic Angiographic Control
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm BoxClass IIJun 30, 2026Potential for breach in sterile barrier of device packaging.
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20Class IIJun 30, 2026Potential for breach in sterile barrier of device packaging.
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing SysClass IIJun 19, 2026Software anomaly occurs when a user adds one or more vials t
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, MaterClass IIJun 11, 2026Boston Scientific's complaint investigations have identified
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CathetClass IIJun 11, 2026Boston Scientific is replacing specific FARASTAR PFA generat
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, MClass IIJun 11, 2026Boston Scientific's complaint investigations have identified
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation CatheterClass IIJun 11, 2026Labeling discrepancy: Devices distributed with Instructions
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heartClass IIJun 11, 2026Boston Scientific's complaint investigations have identified
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterClass IIJun 11, 2026Labeling discrepancy: Devices distributed with Instructions
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CathetClass IIJun 11, 2026Labeling discrepancy: Devices distributed with Instructions
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, MClass IIJun 11, 2026Boston Scientific's complaint investigations have identified
CRE Pro Wireguided 15-18mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Wireguided 12-15mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Pro Wireguided 10-12mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Pro Wireguided 8-10mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Pro Wireguided 6-8mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Wireguided 15-18mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Pro Wireguided 12-15mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Wireguided 8-10mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Wireguided 18-20mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Pro Wireguided 18-20mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Wireguided 6-8mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
CRE Wireguided 10-12mm 240cmClass IIMay 21, 2026Potential sterile breach of the pouches in which devices are
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to Class IIMay 12, 2026Boston Scientific is initiating a medical device removal of
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery deviceClass IIMay 11, 2026There is the potential for leakage along the drug pathway fr
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, VersioClass IIMar 30, 2026For some patients upgraded from a LUX-Dx M301 device to a ne
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5Class IIMar 30, 2026For some patients upgraded from a LUX-Dx M301 device to a ne
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled asClass IMar 19, 2026Updated software, Brady software maintenance release 6 (SMR6
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VAClass IMar 19, 2026Updated software, Brady software maintenance release 6 (SMR6
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;Class IIFeb 10, 2026Recall of kits which utilized ChloraPrep Triple Swabsticks f
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;Class IDec 19, 2025Increased reports of stent deployment and expansion issues.
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;Class IDec 19, 2025Increased reports of stent deployment and expansion issues.
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;Class IDec 19, 2025Increased reports of stent deployment and expansion issues.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;Class IDec 19, 2025Increased reports of stent deployment and expansion issues.
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;Class IDec 19, 2025Increased reports of stent deployment and expansion issues.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;Class IDec 19, 2025Increased reports of stent deployment and expansion issues.
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF HClass IIDec 3, 2025Boston Scientific is initiating the removal of certain batch
TENACIO Pump with InhibiZone; UPN: 72404429;Class IISep 11, 2025The potential for devices to experience inflation and/or def
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) Class IISep 11, 2025The potential for devices to experience inflation and/or def
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) Class IISep 11, 2025The potential for devices to experience inflation and/or def
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 7Class IISep 11, 2025The potential for devices to experience inflation and/or def
TENACIO Pump without InhibiZone; UPN: 72404420;Class IISep 11, 2025The potential for devices to experience inflation and/or def
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);Class IISep 11, 2025The potential for devices to experience inflation and/or def
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);Class IISep 11, 2025The potential for devices to experience inflation and/or def
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);Class IIAug 28, 2025The product in incorrectly labeled. The label indicates that
ACCOLADE DR EL (Model L321)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number U125, VALITUDE CRT-P ELClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number S701 ALTRUA 2 SR SL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
ACCOLADE DR EL MRI (Model L331)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L111, ESSENTIO DR SL MRI PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number U128, VALITUDE CRT-P EL MRIClass IAug 20, 2025Software to enhance Safety Architecture is available and des
ACCOLADE SR SL MRI (Model L310)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number U226, VISIONIST CRT-P ELClass IAug 20, 2025Software to enhance Safety Architecture is available and des
ACCOLADE DR SL (Model L301)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number S702, ALTRUA 2 DR SL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
ACCOLADE SR SL (Model L300)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L110, ESSENTIO SR SL MRI PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L101, ESSENTIO DR SL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L121 ESSENTIO DR EL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
ACCOLADE DR SL MRI (Model L311)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number U225 VISIONIST CRT-P ELClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L210 PROPONENT SR SL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
PROPONENT SR SL (Model L200)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
PROPONENT DR SL (Model L201)Class IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L231, PROPONENT DR EL MRI PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L131, ESSENTIO DR EL MRI PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L100, ESSENTIO SR SL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number U228, VISIONIST CRT-P EL MRIClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L211 PROPONENT DR SL MRI PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L209 PROPONENT DR (VDD) SL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number L221 PROPONENT DR EL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
Model Number S722, ALTRUA 2 DR EL PacemakerClass IAug 20, 2025Software to enhance Safety Architecture is available and des
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0Class IIAug 18, 2025Certain desiccant tube subassemblies were built with end cap
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000Class IIAug 18, 2025Certain desiccant tube subassemblies were built with end cap
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (InterventioClass IIAug 5, 2025The Encore 26 Inflation Device is used with balloon dilation
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. Class IIAug 5, 2025The Encore 26 Inflation Device is used with balloon dilation
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M00671Class IIAug 5, 2025The Encore 26 Inflation Device is used with balloon dilation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)Class IIAug 5, 2025The Encore 26 Inflation Device is used with balloon dilation
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal Class IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal Class IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptalClass IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptaClass IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal acceClass IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptaClass IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptalClass IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal Class IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptalClass IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal Class IJul 29, 2025Boston Scientific has identified a higher likelihood of air
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal Class IJul 29, 2025Boston Scientific has identified a higher likelihood of air
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 016Class IJul 24, 2025Affected lead models may experience gradually rising LVSI me
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; ModeClass IJul 24, 2025Affected lead models may experience gradually rising LVSI me
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Class IJul 24, 2025Affected lead models may experience gradually rising LVSI me
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. MaterialClass IJul 7, 2025Certain batches are being removed due to an increase in comp
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401Class IIJun 25, 2025The potentially impacted units were manufactured using speci
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18Class IIJun 10, 2025Potential for hole in the Tyvek layer of the sterile barrier
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 DevicClass IIJun 10, 2025Potential for hole in the Tyvek layer of the sterile barrier
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROClass IIJun 10, 2025Potential for hole in the Tyvek layer of the sterile barrier
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F Class IIJun 10, 2025Potential for hole in the Tyvek layer of the sterile barrier
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure Class IIMar 24, 2025Boston Scientific has identified that IceSeedTM CX needles m
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gClass IIMar 24, 2025Boston Scientific has identified that IceSeedTM CX needles m
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gaClass IIMar 24, 2025Boston Scientific has identified that IceSeedTM CX needles m
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressureClass IIMar 24, 2025Boston Scientific has identified that IceSeedTM CX needles m
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640Class IIDec 20, 2024Reported Outer sheath distal black tip detaching from the de
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)Class IDec 12, 2024A subset of devices from the ACCOLADE Family of Pacemakers a
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model NumbClass IDec 12, 2024A subset of devices from the ACCOLADE Family of Pacemakers a
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model NumbClass IDec 12, 2024A subset of devices from the ACCOLADE Family of Pacemakers a
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model NumClass IDec 12, 2024A subset of devices from the ACCOLADE Family of Pacemakers a
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)Class IDec 12, 2024A subset of devices from the ACCOLADE Family of Pacemakers a
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)Class IDec 12, 2024A subset of devices from the ACCOLADE Family of Pacemakers a
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OClass IIOct 28, 2024Potential for mislabeled packaging in which a device labeled
AMS Artificial Urinary Sphincter Control PumpClass IIOct 28, 2024Potential for mislabeled packaging in which a device labeled
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100Class IOct 10, 2024Boston Scientific is updating the instructions for use of th
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, caClass IISep 6, 2024Patients using the Model 2939 myLUX Patient Application on t
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive disClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an Class IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an intClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes anClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactivClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an Class IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an inteClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes anClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an Class IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an intClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an intClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive Class IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes aClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes anClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes aClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive Class IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactiClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive disClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an intClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an Class IISep 5, 2024Boston Scientific has received reports indicating the grid m
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactiClass IISep 5, 2024Boston Scientific has received reports indicating the grid m
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended foClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is IntendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System InteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntenClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntenClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntendClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntenClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended foClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Class IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntendClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is IntendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntenClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended forClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures causedClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System IntenClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is IntendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System InteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is IntendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is IntendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is IntendeClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent SysteClass IIAug 1, 2024WallFlexTM Esophageal Stent System and AgileTM Esophageal Ov
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uriClass IIJul 18, 2024There is the potential for holes in the clear sterile barrie
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a peClass IIJul 18, 2024There is the potential for holes in the clear sterile barrie
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose draiClass IIJul 18, 2024There is the potential for holes in the clear sterile barrie
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking piClass IIJul 18, 2024There is the potential for holes in the clear sterile barrie
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of thClass IIJul 18, 2024There is the potential for holes in the clear sterile barrie
Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicianClass IIJun 27, 2024Some lots of Capio SLIM do not consistently catch the suture
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIClass IIJun 27, 2024Some lots of Capio SLIM do not consistently catch the suture
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cClass IIJun 12, 2024Foreign material may be present on the enclosed section of t
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheterClass IMar 21, 2024An increase in complaints related to an inability to advance
OptiCross Coronary Imaging Catheter, REF H749518080120Class IIMar 5, 2024Certain batches of Opticross 40MHz Coronary Imaging Cathete
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric Class IIFeb 20, 2024Inability to advance the guidewire through the feeding tube
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedClass IIFeb 20, 2024Inability to advance the guidewire through the feeding tube
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010Class IFeb 20, 2024An investigation determined that delivery of the Obsidio emb
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediClass IIFeb 20, 2024Inability to advance the guidewire through the feeding tube
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric anClass IIFeb 20, 2024Inability to advance the guidewire through the feeding tube
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular systemClass IIFeb 20, 2024Boston Scientific is conducting a removal of specific batche
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both peClass IIFeb 20, 2024Inability to advance the guidewire through the feeding tube
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050Class IFeb 12, 2024Boston Scientific has identified a tooling error in manufact
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.Class IIDec 19, 2023Affected batches of the kit contain Stoma Measuring Devices
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer ApplicClass IINov 30, 2023The software application on the Programmer/Recorder/Monitor
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M005Class IISep 27, 2023Poor image quality due to fluid ingress in the lens.
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.Class IISep 27, 2023Poor image quality due to fluid ingress in the lens.
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheterClass IIJul 27, 2023Stryker Neurovascular has observed that certain lots of Guid
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter DefibrillatorClass IIJul 11, 2023There is a potential for a rare interaction between the EMBL
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter DefibrillatorClass IIJul 11, 2023There is a potential for a rare interaction between the EMBL
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to uroloClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy fClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy frClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to uroloClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleareClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from clearClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from clClass IIMay 25, 2023Manufactured with the incorrect component may result in lowe
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)Class IIApr 5, 2023The firm received complaints of the Insertion Tool component
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)Class IIApr 5, 2023The firm received complaints of the Insertion Tool component
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar eneClass IIFeb 2, 2023Cease use of the Habib EndoHPB Bipolar RF Catheter with the
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.Class IIFeb 2, 2023Under specific circumstances, the U.S. product registration
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic EndovascClass IIOct 13, 2022Consoles were shipped without an instruction for use (IFU) o
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucoClass IIOct 10, 2022***Update12/13/22***:Product removal due to higher incidence
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polypsClass IIOct 10, 2022***Update12/13/22***:Product removal due to higher incidence
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of pClass IIOct 10, 2022***Update12/13/22***:Product removal due to higher incidence
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.Class IISep 30, 2022There is an incorrect manufacturing date/timestamp within th
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.Class IISep 30, 2022There is an incorrect manufacturing date/timestamp within th
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440Class IIAug 9, 2022The impacted products were distributed with an MPXF tip curv
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicClass IIJul 7, 2022There is potential for unanticipated software anomalies to o
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific impClass IIJul 7, 2022There is potential for unanticipated software anomalies to o
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific impClass IIJul 7, 2022There is potential for unanticipated software anomalies to o
GreenLight HPSEA Laser Fibers, UPN 0010-2092Class IIIMay 31, 2022Several complaints were received for the affected lot; users
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC cClass IIMay 25, 2022Product may be mislabeled.
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC cClass IIMay 25, 2022Product may be mislabeled.
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive FloppyClass IIMar 8, 2022Pouch seals may be open, compromising sterility.
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra SupportClass IIMar 8, 2022Pouch seals may be open, compromising sterility.
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duoClass IIMar 3, 2022Updated Instructions for Use (IFU) for EXALT Model D Single
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duClass IIMar 3, 2022Updated Instructions for Use (IFU) for EXALT Model D Single
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodClass IIMar 3, 2022Updated Instructions for Use (IFU) for EXALT Model D Single
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duClass IIMar 3, 2022Updated Instructions for Use (IFU) for EXALT Model D Single
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostClass IIFeb 24, 2022Users need to be aware that embolism is a possible adverse e
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall awayClass IIFeb 24, 2022Users need to be aware that embolism is a possible adverse e
DREAMTOME 49-30MM/260CM Material Number: M00584010Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 49-30-260-035 Material Number: M00573020Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
HYDRATOME RX 44-20MM/450CM Material Number: M00583060Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 39-30-260-025 Material Number: M00573100Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 44-20-260-035 Material Number: M00573040Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 49-30-450-035 Material Number: M00573030Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
DREAMTOME 49-30MM/450CM Material Number: M00584030Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
DREAMTOME 49-20MM/450CM Material Number: M00584020Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 39-30-260-025 Material Number: M00573100Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
DREAMTOME 44-30MM/260CM Material Number: M00584050Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
DREAMTOME 49-20MM/260CM Material Number: M00584000Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
HYDRATOME RX 49-20MM/260CM Material Number: M00583000Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 44-20-450-035 Material Number: M00573050Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 39-20-260-025 Material Number: M00573080Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
HYDRATOME RX 44-20MM/260CM Material Number: M00583040Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 44-30-450-035 Material Number: M00573070Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
HYDRATOME RX 44-30MM/260CM Material Number: M00583050Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 44-30-260-035 Material Number: M00573060Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
HYDRATOME RX 49-30MM/260CM Material Number: M00583010Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 39-30-450-025 Material Number: M00573110Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
HYDRATOME RX 44-30MM/450CM Material Number: M00583070Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 39-20-450-025 Material Number: M00573090Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
JAGTOME RX 49-20-260-035 Material Number: M00573000Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
DREAMTOME 44-30MM/450CM Material Number: M00584070Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M0Class IIDec 22, 2021Sterility of device is compromised due to a sterile barrier
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).Class IINov 8, 2021Manufacturing instructions did not include the directions to
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter Class IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Class IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of OClass IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter ofClass IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter ofClass IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of OClass IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of OClass IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Class IIOct 21, 2021Balloon pinhole results in losss pressure or fails to gain o
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)Class IIJul 23, 2021Potential for leaks and loosening at the patient catheter co
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)Class IIJul 23, 2021Potential for leaks and loosening at the patient catheter co
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128Class IIJun 3, 2021Latent release of small amounts of hydrogen within the pacem
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131Class IIJun 3, 2021Latent release of small amounts of hydrogen within the pacem
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 Class IJun 3, 2021The dual chamber INGENIO family pacemakers or cardiac resync
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 Class IJun 3, 2021The dual chamber INGENIO family pacemakers or cardiac resync
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722Class IIJun 3, 2021Latent release of small amounts of hydrogen within the pacem
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (Class IJun 3, 2021The dual chamber INGENIO family pacemakers or cardiac resync
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228Class IIJun 3, 2021Latent release of small amounts of hydrogen within the pacem
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173Class IJun 3, 2021The dual chamber INGENIO family pacemakers or cardiac resync
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331Class IIJun 3, 2021Latent release of small amounts of hydrogen within the pacem
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)Class IJun 3, 2021The dual chamber INGENIO family pacemakers or cardiac resync
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273Class IJun 3, 2021The dual chamber INGENIO family pacemakers or cardiac resync
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231Class IIJun 3, 2021Latent release of small amounts of hydrogen within the pacem
ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of Class IIApr 21, 2021One batch of the ELUVIATM Drug Eluting Vascular Stent System
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in thClass IIApr 15, 2021Potential for pinholes (sterile barrier breach) on the edge
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging materialClass IIApr 15, 2021Potential for pinholes (sterile barrier breach) on the edge
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for Class IApr 12, 2021The firm has received reports of stent migration after impla
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vaClass IApr 12, 2021The firm has received reports of stent migration after impla
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of sClass IIMar 26, 2021An AMS 700 100 mL Spherical Reservoir with InhibiZone was in
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatmenClass IIIMar 16, 2021May have been programmed with a less than optimal brightness
MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and plClass IIMar 5, 2021The firm initiated a removal of certain batches of MAMBA 135
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labelClass IIMar 5, 2021The firm initiated a removal of certain batches of MAMBA 135
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00Class IIJan 19, 2021Packaging Incomplete Seal. Users noted an incomplete pouch s
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311Class IIJan 19, 2021Packaging Incomplete Seal. Users noted an incomplete pouch s
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: Class IIJan 19, 2021Packaging Incomplete Seal. Users noted an incomplete pouch s

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