FDAHealthSeptember 12, 2025
Medtronic Perfusion Systems — Affinity 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.
Is this relevant to me?
- Geography
- US, AZ, CA, TN
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
US States: AZ, CA, TN
What's affected?
- Product
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
- Lot code
- 231621003
Additional details
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 26 units.
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