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Medtronic Perfusion Systems FDA Recalls
96 recalls on file across devices, 15 of them Class I and 61 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retuClass IIJun 24, 2026Pinhole leaks may occur in the wire-wound body during cardio |
| EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial returnClass IIJun 24, 2026Pinhole leaks may occur in the wire-wound body during cardio |
| EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retuClass IIJun 24, 2026Pinhole leaks may occur in the wire-wound body during cardio |
| EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, ModelClass IIJun 24, 2026Pinhole leaks may occur in the wire-wound body during cardio |
| EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial returnClass IIJun 24, 2026Pinhole leaks may occur in the wire-wound body during cardio |
| EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number Class IIJun 24, 2026Pinhole leaks may occur in the wire-wound body during cardio |
| Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannulaClass IIMay 25, 2026Medtronic received two complaints of loose foreign material |
| Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannulaClass IIMay 25, 2026Medtronic received two complaints of loose foreign material |
| Octopus Evolution AS Tissue Stabilizer, Model TS2500Class IIMay 12, 2026During the manufacturing process, Medtronic personnel identi |
| Octopus 4 Tissue Stabilizer, Model 29400Class IIMay 12, 2026During the manufacturing process, Medtronic personnel identi |
| Octopus Evolution Tissue Stabilizer, Model TS2000Class IIMay 12, 2026During the manufacturing process, Medtronic personnel identi |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular caClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascularClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular cClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular caClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catClass IIApr 21, 2026Certain lots of product have the potential for a sterile bar |
| Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1Class IIJan 13, 2026During the manufacturing, Medtronic personnel identified an |
| Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03Class IIOct 20, 2025Medtronic personnel observed trace amounts of dry blood on t |
| MC3 VitalFlow Console, REF 58100; Blood pump of ecmoClass IIOct 3, 2025As of August 6, 2025, Medtronic has received eleven reports |
| Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541BClass IISep 12, 2025Medtronic identified an Affinity NT Oxygenator unit with dec |
| DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113Class IAug 6, 2025The catheters may not retain their shape. |
| DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115Class IAug 6, 2025The catheters may not retain their shape. |
| DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110Class IAug 6, 2025The catheters may not retain their shape. |
| Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 Class IFeb 5, 2025Unexpected loose material in the male luer used in the aorti |
| EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)Class IIDec 12, 2024Incorrect labeling for seven manufactured lots of certain mo |
| Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)Class IIDec 12, 2024Incorrect labeling for seven manufactured lots of certain mo |
| DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)Class IIDec 12, 2024Incorrect labeling for seven manufactured lots of certain mo |
| Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgeryClass IIOct 3, 2024There is the potential for a potential sterility breach for |
| Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312Class IIJul 9, 2024During manufacturing, DLP Single Stage Venous Cannulae - str |
| TourniKwik Tourniquet Set (CFN 79012)Class IIMay 16, 2024Incorrect component placed in four manufactured lots of the |
| Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent CClass IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic DLP Coronary Ostial Cannulae, Model Number 30050Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DClass IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr.Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in),Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction TuClass IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Clearview Blower/Mister, Model Number 22120Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) TournClass IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.2Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001Class IIMar 19, 2024Potential for unsealed sterile packing. |
| Medtronic DLP Vessel Cannula, Model Number REF 30000Class IIFeb 7, 2024Medtronic is writing to inform you of incorrect labeling for |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in CarClass IIDec 12, 2022An upward trend of complaints in which the Temperature Monit |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in CarClass IIDec 12, 2022An upward trend of complaints in which the Temperature Monit |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE Class IIDec 12, 2022An upward trend of complaints in which the Temperature Monit |
| Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance BioClass IIDec 12, 2022An upward trend of complaints in which the Temperature Monit |
| Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance BioClass IIDec 12, 2022An upward trend of complaints in which the Temperature Monit |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in CarClass IIDec 12, 2022An upward trend of complaints in which the Temperature Monit |
| Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plasClass IIApr 20, 2022Firm detected an increase in complaints related to fractured |
| Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM Class IIOct 12, 2021Product is labeled as non-pyrogenic but endotoxin testing wa |
| Cardioblate CryoFlex Surgical Ablation ConsoleClass IISep 27, 2021There is potential for intermittent electrical connectivity |
| Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, VenoClass IISep 13, 2021There was a label mix-up between two model numbers resulting |
| DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx OnlyClass IIAug 24, 2021Potential for a wire protrusion through the left heart vent |
| DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx OnlyClass IIAug 24, 2021Potential for a wire protrusion through the left heart vent |
| Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.Class IIApr 29, 2021Specific lots may have been manufactured with insufficient o |
| Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1Class IMar 3, 2021An electrical component within the system controller module |
| Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie CardiotClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) witClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous ReservClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous ReservClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Class IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CClass IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Class IFeb 4, 2021Products being recalled due to potentially elevated level of |
| Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with BalaClass IFeb 4, 2021Products being recalled due to potentially elevated level of |