Medtronic recalls Custom Perfusion System (BB7W03R8 CCSM NEON) due to potential bacterial endotoxin levels causing 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 Custom Perfusion System (BB7W03R8 CCSM NEON) because it may contain elevated bacterial endotoxins that can cause severe inflammatory reactions in patients. This device is used during heart surgery to collect and store blood. Patients using this device during surgery are at risk of serious health effects if the endotoxin levels are too high.
The device may contain elevated levels of bacterial endotoxins, which can trigger an acute inflammatory response in patients. This reaction could lead to serious health complications during heart surgery when blood is being circulated outside the body.
Patients undergoing heart surgery using this specific perfusion system are at risk. Healthcare providers using the device for extracorporeal circulation are also affected.
Check for the model number BB7W03R8 on the device packaging or label. The product was sold with the lot number 220911945.
Reach out to Medtronic Perfusion Systems directly to confirm if your device is affected and get guidance on next steps.
The recall indicates potential bacterial endotoxin levels that could cause serious health issues, so it is not safe to use without verification from Medtronic.
Contact Medtronic Perfusion Systems to determine if your device is affected and follow their instructions.
Look for the model number BB7W03R8 on the device packaging or label, and check the lot number 220911945.
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-1199-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1199-2021 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.
