Recall Z-0487-2026 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
| Date | Nov 10, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| Reason | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. |
| 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 gui |
| Quantity | 26 units |
| Distribution | US States: AZ, CA, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface a Medtronic, Inc., Jun 12, 2024 |