Medtronic recalls Kinderset 1/4-1/4 MIT Pixie 1/B devices due to potential bacterial endotoxin levels that may cause acute inflammatory responses in patients.
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 its Kinderset 1/4-1/4 MIT Pixie 1/B blood collection devices because they might contain elevated bacterial endotoxins. This could lead to serious health issues like acute inflammation in patients using the devices during surgery.
The device may contain higher than safe levels of bacterial endotoxins. When patients are exposed to these endotoxins during surgery, they can develop an acute inflammatory response, which is a serious medical condition.
Patients undergoing surgery who use this specific blood collection device are at risk. Healthcare providers using the device for extracorporeal circulation are most affected.
Look for the model number M490817B on the device. The product was sold with lot number 220886950 and is part of the Kinderset 1/4-1/4 MIT Pixie 1/B line.
Verify the model number is M490817B on the device label.
The model number is M490817B.
Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
The recall record does not specify a remedy.
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-1197-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1197-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
