Medtronic recalls custom perfusion packs with elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients. Affected units include specific model HY11B40R1 sold with lot numbers from 2022.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Medtronic is recalling custom perfusion packs that may contain elevated bacterial endotoxins, which can cause severe inflammatory reactions in patients. This risk applies to specific model numbers used in heart-lung machines during surgeries.
The recalled perfusion packs may contain higher levels of bacterial endotoxins than safe limits. When patients are exposed to these toxins during surgery, they can develop sudden and severe inflammation reactions.
Patients undergoing heart-lung machine procedures using the recalled perfusion packs are at risk. Healthcare providers using the specific model numbers are most affected.
Check for the model number HY11B40R1 on the pack. The lot number starts with 220911913. These packs were sold with the generic name Cardiopulmonary bypass oxygenator.
Identify the model number HY11B40R1 and lot number starting with 220911913 on the pack.
The model number is HY11B40R1.
Patients exposed to elevated bacterial endotoxins may develop acute inflammatory responses.
Look for the model number HY11B40R1 and lot number starting with 220911913 on the pack.
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-1195-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1195-2021 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.
