FDA-Device2025-11-19Class IIPROCESSING DEFECT
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Hazard
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Sold states
US States: AZ, CA, TN
Affected count
26 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2026More Medtronic Perfusion Systems recalls
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