Z-0693-2020Class II

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

Name: Z-0693-2020 Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Creator: Medtronic Perfusion Systems
Published: 2019-11-14
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2019-11-14 / Terminated / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 on 2019-11-14. FDA classified it as Class II and gives the reason as "Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0693-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-14
Posted: 2019-12-17
Terminated: 2020-10-05
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Product code: DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Reason for recall: Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beginning 14-Nov-2019, Medtronic initiated an immediate Urgent Medical Device Recall via verbal communication to one (1) customer that was shipped the affected product according to Medtronic records. The customer was asked to identify and quarantine any unused affected product. The immediate communication was followed by a written urgent medical device recall notification beginning on 26-Nov-2019 to communicate the issue to the one (1) customer that received affected product. The consignee was asked to confirm receipt of urgent medical device recall notification via a Customer Confirmation Certificate. Medtronic is seeking the return of the affected product.
Quantity in commerce: 24 units
Distribution: CA
Product codes and lots: UDI 20643169858835, Lot Numbers: 13316512

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0693-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0693-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-17

Product code DTM

K952532Class IIAffinity Arterial Blood FilterAvecor Cardiovascular, Inc. / cleared 1995-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)