FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- Recall number
- Z-0693-2020
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- Status
- Terminated
- Initiated
- 2019-11-14
- Posted
- not on file
- Terminated
- 2020-10-05
- Reason
- Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
- 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
- 24 units
- Distribution
- CA
- Lot, serial or model codes
- UDI 20643169858835, Lot Numbers: 13316512
- 510(k) numbers
- ["K952532"]
- PMA numbers
- not on file
- Product code
- DTM
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28