Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Recalled by Medtronic Perfusion Systems Due to An upward trend of complaints in which the...
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
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Quantity: 2,937 units
Why Was This Recalled?
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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