Medtronic Perfusion Systems: Device Recall

Recall #Z-0539-2026 · 10/20/2025

Class II: Risk

Recall Details

Recall Number: Z-0539-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medtronic Perfusion Systems
Status: Ongoing
Date Initiated: 10/20/2025
Location: Brooklyn Park, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3850 units

Reason for Recall

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.

Product Description

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Distribution Pattern

US Nationwide distribution in the states of Hawaii and New York.

Other Recalls by Medtronic Perfusion Systems

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 II: Risk 09/12/2025

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