Medtronic recalls Affinity Pixie Cardiotomy/Venous Reservoir (CVR) devices due to potential elevated 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 Affinity Pixie Cardiotomy/Venous Reservoir (CVR) devices because they may contain elevated levels of bacterial endotoxins. This could lead to acute inflammatory responses in patients using the device during surgery. The recall affects specific model numbers and lot numbers.
The recalled CVR devices may contain elevated 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 reaction.
Patients undergoing surgery who use the recalled CVR devices are at risk. Healthcare providers using the specific model numbers and lot numbers listed in the recall are most affected.
Check for the model number HY10J00R6 and lot number 220768819 on the device packaging. The device is labeled as 'CUSTOM PACK HY10J00R6 ECC SMALL CAR' and is used in cardiac surgery procedures.
Look for the model number HY10J00R6 and lot number 220768819 on the device packaging.
The specific model number is HY10J00R6.
The lot number is 220768819.
The device may contain elevated levels of bacterial endotoxins that can cause acute inflammatory responses in patients.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1192-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1192-2021 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.
