Medtronic Perfusion Systems recalls Affinity NT Oxygenator

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

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

An Urgent: Medical Device Recall notification letter dated September 2025 was sent to customers. Patient Recommendations: Patient previously supported with the impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures. Customer Actions: Medtronic requests that you take the following actions: Review your inventory for listed lot number. If your inventory contains a product with Lot Number 231621003, please refer to the NT Affinity Oxygenator to identify the Serial Number. For guidance, consult Attachment A Identifying Affected Product. If you have the unit with Serial Number 5117755016 immediately quarantine and return it to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of this unit. Your Medtronic sales representative can assist you in the return of unit as necessary. Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have the affected product in your possession. Please maintain a copy of this communication in your records. Medtronic: Report complaints at 1-800-854-3570, option 4, or email to rs.structuralheartfieldassurance@medtronic.com. If you have any questions regarding this communication, please contact your Medtronic Field Representative.

• FDA enforcement recordOfficial FDA database entry for Z-0487-2026
• FDA 510(k) clearance · K241352The device's official FDA premarket clearance record
• FDA device classification · DTZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic Perfusion SystemsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.