Z-0487-2026Class II

Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product...

Name: Z-0487-2026 Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product...
Creator: Medtronic Perfusion Systems
Published: 2025-09-12
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2025-09-12 / Open, Classified

FDA source

Medtronic Perfusion Systems began a recall of Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B on 2025-09-12. FDA classified it as Class II and gives the reason as "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0487-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-12
Posted: 2025-11-10
Recalling firm: Medtronic Perfusion Systems
Product: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 26 units
Distribution: US States: AZ, CA, TN
Product codes and lots: Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0487-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0487-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-10

Product code DTZ

K241352Class IIAffinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)Medtronic, Inc. / cleared 2024-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)