FDA Device Recalls

Recalls / Firms / Medtronic Perfusion Systems

Medtronic Perfusion Systems

121 FDA device recalls on record.

DateClassProductReason
2026-01-13Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
2025-10-20Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
2025-10-03MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
2025-09-12Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir,
2025-08-06DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model
2025-08-06DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model
2025-08-06DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model
2025-02-05Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 1101
2024-12-12EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
2024-12-12Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
2024-12-12DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
2024-10-03Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surg
2024-07-09Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
2024-05-16TourniKwik Tourniquet Set (CFN 79012)
2024-03-19Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP 7 in
2024-03-19Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP L
2024-03-19Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula,
2024-03-19Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 1
2024-03-19Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, M
2024-03-19Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b
2024-03-19Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100;
2024-03-19Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
2024-03-19Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120
2024-03-19Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
2024-03-19Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm
2024-03-19Medtronic Clearview Blower/Mister, Model Number 22120
2024-03-19Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Nu
2024-02-07Medtronic DLP Vessel Cannula, Model Number REF 30000
2022-12-12Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Fi
2022-12-12Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF
2022-12-12Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB8
2022-12-12Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF
2022-12-12Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF
2022-12-12Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Fi
2022-04-20Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray
2021-10-12Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model num
2021-09-27Cardioblate CryoFlex Surgical Ablation Console
2021-09-13Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Mode
2021-08-24DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
2021-08-24DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
2021-04-29Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
2021-04-29Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
2021-04-29Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, St
2021-04-29Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, R
2021-04-29Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
2021-04-29Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
2021-03-03Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BC
2021-02-04Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance
2021-02-04Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Af
2021-02-04Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Card
2021-02-04Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosur
2021-02-04Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir
2021-02-04Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reser
2021-02-04Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy
2021-02-04Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Card
2021-02-04Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixi
2021-02-04Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous
2019-11-14Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
2018-11-27RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated fo
2018-11-27SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are i
2018-08-08Extra corporeal circuit with bio-active surface.
2018-02-08BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) i
2018-01-16Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardio
2018-01-16Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurfa
2018-01-03Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopul
2017-06-22DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pres
2017-06-22DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an anteg
2017-06-22DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near th
2017-06-22DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressu
2017-06-22DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary byp
2016-02-04Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS)
2015-10-28Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene
2015-08-18MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72
2015-08-18MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's
2015-07-24Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blo
2015-06-12Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Repl
2014-10-31The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a si
2011-09-09Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylen
2011-09-09Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring press
2011-09-09Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following
2010-09-13Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a di
2008-05-09Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB8112
2008-05-09Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71
2008-05-09Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Res
2008-05-09Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only
2008-05-09Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB9
2008-05-09Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascular Cardiop
2008-05-09Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015
2008-05-09Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Sur
2008-05-09Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound PVC bodies w
2008-05-09Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catal
2008-05-09Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Cata
2008-05-09Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number:
2007-10-01Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis,
2007-10-01Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [P
2007-08-01Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-
2007-06-04Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System i
2007-04-18Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer:
2007-01-02Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them
2006-09-13Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product we
2005-03-25Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components s
2004-03-25Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir w