Medtronic Perfusion Systems: Device Recall

Recall #Z-0487-2026 · 09/12/2025

Class II: Risk

Recall Details

Recall Number: Z-0487-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medtronic Perfusion Systems
Status: Ongoing
Date Initiated: 09/12/2025
Location: Brooklyn Park, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26 units

Reason for Recall

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

Product Description

Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Distribution Pattern

US States: AZ, CA, TN

Other Recalls by Medtronic Perfusion Systems

Class II: Risk 10/20/2025

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.
Class II: Risk 10/03/2025

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.
Class I: Dangerous 08/06/2025

The catheters may not retain their shape.
Class I: Dangerous 08/06/2025

The catheters may not retain their shape.
Class I: Dangerous 08/06/2025

The catheters may not retain their shape.

View all recalls by Medtronic Perfusion Systems →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.