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Medtronic Perfusion Systems Recalls
116 recalls on record · December 17, 2014 to August 5, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
June 23, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Hazard: Specific lots may have been manufactured with insufficient or incomplete welds.
April 7, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1
Hazard: An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
March 24, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Bala
Hazard: Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
March 24, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reserv
Hazard: Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
March 24, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous
Hazard: Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
March 24, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance
Hazard: Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.