Medtronic recalls Affinity 38um Arterial Filters with excess plastic (flash) that could cause blockages. Affected units have specific catalog and lot numbers.
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Medtronic is recalling its Affinity 38um Arterial Filters due to excess plastic (flash) in the filter that could cause blockages. This issue affects specific units with catalog number REF 351 and lot numbers 13316512.
The filter has excess plastic (flash) that could cause blockages in the arterial system. This might lead to reduced blood flow or other complications during medical procedures.
Users of the Medtronic Affinity 38um Arterial Filter with catalog number REF 351 and lot numbers 13316512 are affected. Patients using this filter for medical purposes are most at risk.
Check for the catalog number REF 351 and lot numbers 13316512 on the filter. The product was sold with the unique device identifier (UDI) 20643169858835.
Verify the catalog number REF 351 and lot numbers 13316512 on the filter.
The filter has excess plastic (flash) that could cause blockages in the arterial system.
Check for catalog number REF 351 and lot numbers 13316512 on the filter.
The recall does not specify a stop-use action, so you can continue using it if it's not affected.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0693-2020 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-0693-2020 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
