Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reported: November 19, 2025 Initiated: September 12, 2025 #Z-0487-2026
Product Description
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason for Recall
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 26 units
- Distribution
- US States: AZ, CA, TN
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B. Recalled by Medtronic Perfusion Systems. Units affected: 26 units.
Why was this product recalled? ▼
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0487-2026.
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