ARROW INTERNATIONAL Inc. FDA Recalls

57 recalls on file across devices, 46 of them Class I and 48 still open. This firm is not matched to a listed company.

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

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Product	Reason	Class	Initiated
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Class IIJul 26, 2024Reports have been received regarding open seals on the packa	Reports have been received regarding open seals on the packaging.	Class IIDevices	Jul 26, 2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWSClass IApr 29, 2024Teleflex received reports indicating an infrequent condition	Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly,	Class IDevices	Apr 29, 2024
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-UClass IApr 29, 2024Teleflex received reports indicating an infrequent condition	Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly,	Class IDevices	Apr 29, 2024
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-UClass IApr 29, 2024Teleflex received reports indicating an infrequent condition	Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly,	Class IDevices	Apr 29, 2024
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-042Class IFeb 12, 2024Teleflex is initiating this voluntary recall for the above-m	Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicati	Class IDevices	Feb 12, 2024
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: PercutClass IIAug 10, 2023This recall has been initiated due to reports that the produ	This recall has been initiated due to reports that the product code and product name were incorrectly listed o	Class IIDevices	Aug 10, 2023
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intraClass IAug 10, 2023This recall has been initiated due to reports that the produ	This recall has been initiated due to reports that the product code and product name were incorrectly listed o	Class IDevices	Aug 10, 2023
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, RClass IAug 10, 2023This recall has been initiated due to reports that the produ	This recall has been initiated due to reports that the product code and product name were incorrectly listed o	Class IDevices	Aug 10, 2023
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascularClass IIAug 10, 2023This recall has been initiated due to reports that the produ	This recall has been initiated due to reports that the product code and product name were incorrectly listed o	Class IIDevices	Aug 10, 2023
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,Class IAug 10, 2023This recall has been initiated due to reports that the produ	This recall has been initiated due to reports that the product code and product name were incorrectly listed o	Class IDevices	Aug 10, 2023
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic,Class IAug 10, 2023This recall has been initiated due to reports that the produ	This recall has been initiated due to reports that the product code and product name were incorrectly listed o	Class IDevices	Aug 10, 2023
ARROW Endurance Extended Dwell Peripheral Catheter SystemClass IMay 19, 2023Potential for catheter separation or leakage	Potential for catheter separation or leakage	Class IDevices	May 19, 2023
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducerClass IOct 27, 2022There is the potential for inadequate connection between the	There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear	Class IDevices	Oct 27, 2022
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-4Class IOct 27, 2022There is the potential for inadequate connection between the	There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear	Class IDevices	Oct 27, 2022
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pumpClass IOct 17, 2022There is a potential issue with short battery run-times on t	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devic	Class IDevices	Oct 17, 2022
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHClass IISep 14, 2022Mislabeling: the corrugate label, lidstock, banner card, a	Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product	Class IIDevices	Sep 14, 2022
Arrow Three-Lumen CVCClass IIMay 5, 2022Gravity flow rates on the affected product lidstock are inco	Gravity flow rates on the affected product lidstock are incorrect.	Class IIDevices	May 5, 2022
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-TrerotClass ISep 20, 20217FR Percutaneous Thrombolytic Device (PTD) Inner lumen (oran	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embo	Class IDevices	Sep 20, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-TrerClass ISep 20, 20217FR Percutaneous Thrombolytic Device (PTD) Inner lumen (oran	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embo	Class IDevices	Sep 20, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-TrerotoClass ISep 20, 20217FR Percutaneous Thrombolytic Device (PTD) Inner lumen (oran	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embo	Class IDevices	Sep 20, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-TrerotClass ISep 20, 20217FR Percutaneous Thrombolytic Device (PTD) Inner lumen (oran	7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embo	Class IDevices	Sep 20, 2021
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary uClass IIMay 19, 2021Marketed without a 510K	Marketed without a 510K	Class IIDevices	May 19, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - ProduClass IIMay 19, 2021Marketed without a 510K	Marketed without a 510K	Class IIDevices	May 19, 2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for Class IIMay 19, 2021Marketed without a 510K	Marketed without a 510K	Class IIDevices	May 19, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - ProductClass IIMay 19, 2021Marketed without a 510K	Marketed without a 510K	Class IIDevices	May 19, 2021
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) PrClass IIMar 8, 2021Difficulty inserting the biopsy ejector rod into the bone le	Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample	Class IIDevices	Mar 8, 2021
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femClass IIJan 6, 2021The lidstock / information card on the kits correctly states	The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card	Class IIDevices	Jan 6, 2021