Medtronic recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance due to Temperature Monitoring Adapter coming loose during setup or disassembly, potentially causing safety issues.
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 Custom Pack Perfusion Tubing Packs with Affinity Fusion Oxygenator models that have a Temperature Monitoring Adapter (TMA) that may come loose during setup or disassembly. This could lead to safety issues during cardiopulmonary bypass procedures.
The Temperature Monitoring Adapter (TMA) on the Affinity Fusion Oxygenator can become loose during pre-procedure setup or post-procedure disassembly. This could disrupt the oxygenator's function during surgery, potentially causing safety issues for patients.
Patients undergoing cardiopulmonary bypass surgery using the recalled tubing packs are most at risk. Healthcare providers using these specific models for surgical procedures may also be affected.
Check for Custom Pack Perfusion Tubing Packs with Affinity Fusion Oxygenator model BB811, serial numbers between 8111483548 and 8113999999, or specific GTIN numbers and model numbers listed in the recall notice.
Identify if your tubing pack has the Affinity Fusion Oxygenator model BB811 with serial numbers between 8111483548 and 8113999999 or the listed GTIN numbers.
Reach out to Medtronic Perfusion Systems for guidance on next steps if your product is affected.
The recall involves Custom Pack Perfusion Tubing Packs with Affinity Fusion Oxygenator model BB811, serial numbers between 8111483548 and 8113999999.
Check for the Affinity Fusion Oxygenator model BB811 with serial numbers between 8111483548 and 8113999999 or the specific GTIN numbers listed in the recall notice.
Contact Medtronic Perfusion Systems for guidance on next steps if your product is affected.
We’ve drafted a message you can send Trsmima to request your refund or repair — edit it as you like.
Subject: Recall Z-1027-2023 — Trsmima Trsmima Hello, I own a Trsmima that is covered by recall Z-1027-2023 from Trsmima. 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.
