FDA Enforcement
Class II
Ongoing
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Recall: Z-0487-2026
·
Reported November 19, 2025
Enforcement
- Recall Number
- Z-0487-2026
- Event ID
- 97702
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Perfusion Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 19, 2025
- Initiation Date
- September 12, 2025
- Classification Date
- November 10, 2025
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States
Description
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Code Info
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Distribution
US States: AZ, CA, TN
Quantity
26 units