CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

Medtronic Affinity, 38um Arterial Filter recalled

Medtronic Perfusion Systems is recalling Medtronic Affinity, 38um Arterial Filter, distributed in California. The recall was initiated on 14 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 20643169858835, Lot Numbers: 13316512

Quantity recalled24 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0693-2020
FDA event ID: 84410
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Terminated
Recall initiated: 14 Nov 2019
FDA classified: 17 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

14 Nov 2019	Recall initiated by company
17 Dec 2019	Classified by FDA	+33 days
25 Dec 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351

Where it was distributed

California

Questions about this recall

Is Medtronic Affinity, 38um Arterial Filter recalled?

Yes. Medtronic Perfusion Systems recalled Medtronic Affinity, 38um Arterial Filter on 14 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0693-2020.

Why was it recalled?

Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

Which lots are affected?

UDI 20643169858835, Lot Numbers: 13316512

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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