Medtronic recalls Affinity Fusion Oxygenators with loose Temperature Monitoring Adapter that could 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 CB811) due to the Temperature Monitoring Adapter coming loose during setup or disassembly. This could lead to improper temperature monitoring during critical surgeries.
The Temperature Monitoring Adapter (TMA) on the oxygenator can become loose during setup or when disassembling the perfusion circuit. This may cause inaccurate temperature readings 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 affected units should check for loose adapters.
Check for model CB811 with serial numbers between 8111483548 and 8113999999. The oxygenator uses custom packs and has specific lot numbers listed in the recall notice.
Inspect the Temperature Monitoring Adapter (TMA) for looseness before use during surgery or equipment setup.
The recall is due to the Temperature Monitoring Adapter potentially becoming loose, which could cause inaccurate temperature readings during surgery. This may lead to complications but does not guarantee injury.
Check for model CB811 with serial numbers between 8111483548 and 8113999999. The oxygenator uses custom packs and has specific lot numbers listed in the recall notice.
Inspect the Temperature Monitoring Adapter (TMA) for looseness before use during surgery or equipment setup. If loose, contact Medtronic for further 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-1025-2023 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1025-2023 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.
