Medtronic recalls specific lots of BB8M63R5 Adult ECC perfusion systems due to potential insufficient welds. Affected units may have safety risks requiring immediate action.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of BB8M63R5 Adult ECC perfusion systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to safety issues if the device fails during use.
Insufficient or incomplete welds in the perfusion system could cause leaks or failures during operation. This might lead to complications for patients using the device, though the exact risk level is not specified in the recall.
Patients using the Medtronic BB8M63R5 Adult ECC perfusion system are most at risk. The recall affects specific lots manufactured between 2022-10-22 and the lot number 221249911.
Check for the lot number 221249911 on the device packaging. The product was sold with a use-by date of 2022-10-22 and GTIN 00763000458133.
Look for the lot number 221249911 on the packaging or device label.
The recalled product is the Medtronic BB8M63R5 Adult ECC perfusion system.
The recall record does not specify a remedy.
Check for the lot number 221249911 on the packaging or device label. The product was sold with a use-by date of 2022-10-22 and GTIN 00763000458133.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1892-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1892-2021 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.
