Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservo...
FDA Recall #Z-0487-2026 — Class II — September 12, 2025
Product Description
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason for Recall
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Recalling Firm
Medtronic Perfusion Systems — Brooklyn Park, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26 units
Distribution
US States: AZ, CA, TN
Code Information
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated