Medtronic recalls Affinity Fusion Oxygenators with loose Temperature Monitoring Adapters that may cause overheating during heart surgery. Affected units have specific serial numbers and lot codes.
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.
Medtronic is recalling Affinity Fusion Oxygenators that may have a loose Temperature Monitoring Adapter, which could lead to overheating during heart surgery. This recall affects specific models with serial numbers between 8111483548 and 8113999999.
The Temperature Monitoring Adapter (TMA) on the oxygenator can become loose during setup or disassembly, potentially causing overheating. This could lead to complications during heart surgery if the temperature monitoring fails.
Patients undergoing heart surgery using the Affinity Fusion Oxygenator with the specified serial numbers are most at risk. Healthcare providers using these devices in cardiopulmonary bypass procedures should check for the issue.
Check if your oxygenator has the model BB811 and serial numbers between 8111483548 and 8113999999. Lot numbers include 13386860, 13386998, and others listed in the recall notice.
Inspect the Temperature Monitoring Adapter (TMA) for looseness on the oxygenator during setup or after disassembly.
The recalled model is Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811.
Check if your oxygenator has the model BB811 and serial numbers between 8111483548 and 8113999999. If it does, inspect the Temperature Monitoring Adapter for looseness.
The recall does not specify a fix; users should check for looseness and contact Medtronic if needed.
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-1023-2023 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1023-2023 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.
