Device product
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Z-0487-2026
Product summary
- Event
- Event 97702
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0487-2026
Official wording
Reason: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Code information: Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Distribution pattern: US States: AZ, CA, TN
Derived failure modes
-
Unknown
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.