Food, drugs, devices › Medtronic Perfusion Systems
Device recall: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic Perfusion Systems (Brooklyn Park, MN) initiated this device recall on 12 Sep 2025; FDA lists 1 product record under event 97702, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Perfusion Systems has 38 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Perfusion Systems, Brooklyn Park, MN.
Reason for recall
"Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements."
Distribution
"US States: AZ, CA, TN"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0487-2026 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | 26 units | Class II | Ongoing | 19 Nov 2025 |
Context
Other enforcement events for Medtronic Perfusion Systems
All 38 events for Medtronic Perfusion Systems
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US States: AZ, CA, TN"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.