Medtronic Affinity, 38um Arterial Filter, Catalog number ... (Medtronic Perfusion Systems) – plastic contamination (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
UDI 20643169858835, Lot Numbers: 13316512
Products Sold
UDI 20643169858835, Lot Numbers: 13316512
Medtronic Perfusion Systems is recalling Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 due to Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026