Medtronic recalls Affinity Fusion Oxygenators with loose Temperature Monitoring Adapter that may cause complications during cardiopulmonary bypass procedures.
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 with Integrated Arterial Filter and Balance Biosurface (model CB841) due to the Temperature Monitoring Adapter potentially coming loose during setup or disassembly. This could lead to temperature monitoring failures during critical cardiac surgery procedures.
The Temperature Monitoring Adapter (TMA) on the oxygenator can become loose during setup or when disassembling the perfusion circuit. This may cause temperature monitoring failures during surgery, potentially leading to complications for patients.
Patients undergoing cardiopulmonary bypass surgery using this specific oxygenator model are most at risk. Healthcare providers using the recalled units in operating rooms should check for the loose adapter.
Check for model CB841 with serial numbers between 8111483548 and 8113999999. The product was sold with specific lot numbers listed in the recall notice.
Inspect the Temperature Monitoring Adapter (TMA) for looseness on the oxygenator during setup or disassembly.
The recall is for potential temperature monitoring failures during surgery, but the hazard does not cause immediate injury or death in normal use.
Check for model CB841 with serial numbers between 8111483548 and 8113999999, or specific lot numbers listed in the recall notice.
Inspect the Temperature Monitoring Adapter for looseness. If loose, contact Medtronic for guidance.
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-1026-2023 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1026-2023 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.
