Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Affinity Recalled by Medtronic Perfusion Systems Due to Medtronic has identified an out of-specification condition exhibiting...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Perfusion Systems directly.
Affected Products
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Quantity: 24 units
Why Was This Recalled?
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Where Was This Sold?
This product was distributed to 1 state: CA
About Medtronic Perfusion Systems
Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report