Class II

Medical Device Recall: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Medtronic Perfusion Systems · September 12, 2025

Reason for Recall

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

Distribution

US States: AZ, CA, TN

States Affected

AZ, CA, TN

Quantity Affected

26 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0487-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medtronic Perfusion Systems Medical Device Recall: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | SafeCheck