Medtronic Perfusion Systems
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Perfusion Systems and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-04FDA-DeviceClass IIOctopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
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.
- 2025-11-26FDA-DeviceClass IIMedtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
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.
- 2025-11-26FDA-DeviceClass IIMC3 VitalFlow Console, REF 58100; Blood pump of ecmo
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.
- 2025-11-19FDA-DeviceClass IIAffinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- 2025-09-10FDA-DeviceClass IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
The catheters may not retain their shape.
- 2025-09-10FDA-DeviceClass IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
- 2025-09-10FDA-DeviceClass IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
The catheters may not retain their shape.
- 2025-03-19FDA-DeviceClass IAortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
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).
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