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U.S. Department of Health and Human Services

Class 2 Device Recall Affinity NT Oxygenator

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 Class 2 Device Recall Affinity NT Oxygenatorsee related information
Date Initiated by FirmSeptember 12, 2025
Date PostedNovember 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0487-2026
Recall Event ID 97702
510(K)NumberK241352 
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
ProductAffinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Code Information Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
FEI Number 1000116158
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information ContactMedtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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.
Quantity in Commerce26 units
DistributionUS States: AZ, CA, TN
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DTZ
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