Medtronic recalls Affinity Pixie Hollow Fiber Oxygenators with potential bacterial endotoxin levels that may cause acute inflammatory responses in patients during extracorporeal circulation.
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 Affinity Pixie Hollow Fiber Oxygenators and Cardiotomy/Venous Reservoirs due to a potential risk of elevated bacterial endotoxins. This could cause serious inflammation in patients receiving these devices during heart surgery.
The oxygenators may contain higher levels of bacterial endotoxins than safe. When patients are exposed to these endotoxins during heart surgery, they can develop a sudden and severe inflammatory reaction.
Patients undergoing heart surgery using the recalled oxygenators are most at risk. Healthcare providers using these devices for extracorporeal circulation should check if their equipment is affected.
Look for the model number BBP241 on the oxygenator. The product was sold with lot numbers listed in the recall notice, including 13344059 through 13353163. The GTIN numbers 20613994746508 and 00643169089037 are also associated with this recall.
Identify the model number (BBP241) and lot numbers on the oxygenator to confirm if it is recalled.
Reach out to your surgical team to determine if you are using a recalled device and if immediate action is needed.
The recall is due to potential elevated levels of bacterial endotoxins that could cause acute inflammation in patients during heart surgery.
Check the model number and lot numbers listed in the recall notice. Contact your healthcare provider to determine if you need to stop using it.
Yes, the recall includes lot numbers from 13344059 through 13353163, with some updates noted in the notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1190-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1190-2021 from Medtronic. 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.
