Brand

Medtronic Perfusion Systems Recalls

70 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Medtronic Perfusion Systems.

70Total Recalls
10Critical
978,827Units Affected
Jan 13, 2026Most Recent
All Recalls

Every Medtronic Perfusion Systems Recall

Sorted by most recent. Click any recall for full details.

70 recalls
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medical Devices·26 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Medical Devices·14 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medical Devices·18 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·11 affected·Apr 29, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardio...
Medical Devices·387 affected·Mar 3, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reserv...
Respiratory Devices·14 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Ba...
Respiratory Devices·4 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) w...
Respiratory Devices·5 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurf...
Respiratory Devices·3 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is...
Respiratory Devices·7 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance ...
Respiratory Devices·4 affected·Feb 4, 2021
High RiskFDA
Medtronic Perfusion Systems
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotran...
Medical Devices·7,587 affected·Nov 27, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Fi...
Medical Devices·8,644 affected·Jan 16, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Surgical Devices·2,914 affected·Jan 3, 2018
High RiskFDA
Medtronic Perfusion Systems
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulm...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fi...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia can...
Medical Devices·63,053 affected·Jun 22, 2017
RecallFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Al...
Medical Devices·9,890 affected·Feb 4, 2016
High RiskFDA
Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and co...
Medical Devices·496 affected·Oct 28, 2015
High RiskFDA
Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, H...
Medical Devices·1,594 affected·Aug 18, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonar...
Cardiac Devices·221 affected·Jul 24, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. ...
Medical Devices·1,304 affected·Jun 12, 2015