FDA recall Z-0487-2026

Medtronic Perfusion Systems · Class II · device

Product

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.

Distribution

US States: AZ, CA, TN

Key facts

Status
Ongoing
Initiation date
2025-09-12
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2026