Medtronic Affinity 38um Arterial Filter Recall: Excess Plastic Risk
Medtronic recalls Affinity 38um Arterial Filters with excess plastic (flash) that could cause blockages. Affected units have specific catalog and lot numbers.
Lower-risk recall
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/66528-medtronic-affinity-38um-arterial-filter-recall-excess-plastic-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66528-medtronic-affinity-38um-arterial-filter-recall-excess-plastic-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0693-2020
Cite this page
“Medtronic Affinity 38um Arterial Filter Recall: Excess Plastic Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66528-medtronic-affinity-38um-arterial-filter-recall-excess-plastic-risk. Based on FDA recall #Z-0693-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0693-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Medtronic Perfusion Systems- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number REF 351 and lot numbers 13316512 on the filter.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0693-2020 (November 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0693-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.