Medtronic recalls Affinity Fusion Oxygenator with Integrated Arterial Filter (BB841 model) due to Temperature Monitoring Adapter potentially coming loose during setup or disassembly, risking improper perfusion.
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 (BB841 model) because the Temperature Monitoring Adapter can become loose during setup or after surgery, which might cause improper blood flow. This is a serious issue for patients undergoing heart surgery.
The Temperature Monitoring Adapter (TMA) on the oxygenator can become loose during pre-surgery setup or post-surgery disassembly. If it becomes loose, it may not properly monitor temperature, leading to improper blood flow during critical surgery.
Patients using this oxygenator during heart surgery are most at risk. The device is used in cardiopulmonary bypass procedures and is typically owned by hospitals or surgical centers.
Look for the model BB841 with serial numbers between 8111483548 and 8113999999. The device is used in heart surgery and has a GTIN number of 00643169354869 or 00643169588660.
Verify if your oxygenator has the model BB841 and serial numbers in the range 8111483548 to 8113999999.
Reach out to Medtronic Perfusion Systems for guidance on next steps if you have the recalled model.
The Temperature Monitoring Adapter (TMA) can become loose during setup or disassembly, which may cause improper blood flow during surgery.
Check if your device has the model BB841 and serial numbers in the specified range. Contact Medtronic Perfusion Systems for further instructions.
The recall indicates a potential issue with temperature monitoring, but the official notice does not specify if this causes serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1024-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1024-2023 from Medtronic. 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.
