Affinity NT recallZ-0487-2026 · Medtronic Perfusion Systems · initiated Sep 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected]. 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 [email protected]. If you have any questions regarding this communication, please contact your Medtronic Field Representative.
Recall details
- Recall number
- Z-0487-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 12, 2025
- Posted by the FDA
- Nov 10, 2025
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 26 units
- Product code
- DTZ
- FDA submissions
- K241352
- Distribution
- US States: AZ, CA, TN
Product description
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Code information (models, lots, serial numbers)
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Affinity NT™ 541BMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall38 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K241352 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Affinity® 95214Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS19 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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