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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.
August 5, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number
Hazard: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
August 5, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model
Hazard: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
August 5, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retu
Hazard: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
August 5, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retu
Hazard: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
August 5, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return
Hazard: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
August 5, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return
Hazard: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
July 22, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Hazard: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
July 22, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Hazard: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
July 1, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Octopus 4 Tissue Stabilizer, Model 29400
Hazard: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
July 1, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Octopus Evolution AS Tissue Stabilizer, Model TS2500
Hazard: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
July 1, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Octopus Evolution Tissue Stabilizer, Model TS2000
Hazard: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular cat
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular cat
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular ca
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular cat
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular cat
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular cat
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular ca
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular c
Hazard: Certain lots of product have the potential for a sterile barrier breach.
May 27, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular
Hazard: Certain lots of product have the potential for a sterile barrier breach.
March 4, 2026Medical DevicesFDA
Medtronic Perfusion Systems recalls Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Hazard: During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
November 26, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Hazard: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
November 26, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Hazard: As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
November 19, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Hazard: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
September 10, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Hazard: The catheters may not retain their shape.
September 10, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Hazard: The catheters may not retain their shape.
September 10, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Hazard: The catheters may not retain their shape.
March 19, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014
Hazard: Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
January 29, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Hazard: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
January 29, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Hazard: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.