Medtronic recalls Affinity NT Oxygenators with decreased CO2 gas transfer rates that may not meet performance requirements. Affected units have specific product numbers and serial codes.
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Medtronic is recalling certain Affinity NT Oxygenators that may not transfer carbon dioxide properly. This could lead to inadequate oxygenation during medical procedures if the device fails.
The oxygenator may not transfer carbon dioxide effectively, which could cause oxygenation issues during medical procedures. This is a performance problem that might not cause immediate harm but requires monitoring.
Patients using this oxygenator during surgery or medical procedures. Healthcare providers who use these devices are most at risk.
Check for Product Number 541B, Lot Number 231621003, or Unit Serial Number 5117755016 on the device. The UDI-DI codes 00763000187842 and 20763000187846 also identify affected units.
Look for Product Number 541B, Lot Number 231621003, or Unit Serial Number 5117755016 on the device.
The oxygenators may not transfer carbon dioxide properly, which could lead to inadequate oxygenation during medical procedures.
Check for Product Number 541B, Lot Number 231621003, or Unit Serial Number 5117755016 on the device.
The recall record does not specify a remedy, so contact Medtronic directly 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-0487-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-0487-2026 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.
