Food, drugs, devices › Medtronic Perfusion Systems
Device recall: Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Medtronic Perfusion Systems (Brooklyn Park, MN) initiated this device recall on 14 Nov 2019; FDA lists 1 product record under event 84410, 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 5 Oct 2020. 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 has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port."
Distribution
"CA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0693-2020 | Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 | 24 units | Class II | Terminated | 25 Dec 2019 |
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 has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port."
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: "CA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Oct 2020. "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.