—#216369

Product

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

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K241352
Affected lot / code info: Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: US States: AZ, CA, TN

Timeline

Recall initiated: 2025-09-12
Posted by FDA: 2025-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216369. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.