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.
Intended for
Adults
Illnesses reported
None reported
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 recalls
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- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
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