Affinity NT Oxygenator (Medtronic) – Gas Transfer Defect (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
Lot Number: 231621003, Unit Serial Number: 5117755016, UDI-DI: 00763000187842, 20763000187846
Products Sold
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Medtronic Perfusion Systems is recalling Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, due to Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, TN
Page updated: Jan 10, 2026