Recall of 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 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 Custom Pack Perfusion Tubing Packs with Affinity Fusion Oxygenators that have a Temperature Monitoring Adapter (TMA) which may become loose during setup or after disassembly. This could lead to improper temperature monitoring during cardiopulmonary bypass procedures, risking complications for patients.
The Temperature Monitoring Adapter (TMA) on the Affinity Fusion Oxygenator can become loose during pre-procedure setup or post-procedure disassembly. This may cause improper temperature monitoring during cardiopulmonary bypass procedures, potentially leading to complications 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 CB811, serial numbers between 8111483548 and 8113999999, or specific GTIN numbers and lot numbers listed in the recall notice.
Inspect the Temperature Monitoring Adapter (TMA) on the Affinity Fusion Oxygenator to ensure it is securely attached during setup and disassembly.
The recalled model is Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance, model CB811.
Check the serial number range (8111483548 - 8113999999) or specific GTIN numbers and lot numbers listed in the recall notice.
The recall indicates an upward trend of complaints where the Temperature Monitoring Adapter became loose, potentially causing complications during cardiopulmonary bypass procedures, but the remedy does not specify a risk of serious injury.
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-1028-2023 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1028-2023 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.
