Medtronic recalls specific lots of Custom 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 Custom 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 device could cause it to fail during use, potentially leading to safety risks. The exact mechanism of failure is not clearly described in the recall notice.
Patients using the Custom Perfusion System with the specific lot numbers mentioned in the recall are affected. Those who have the device and are at risk of complications from improper welds are most concerned.
Check for the lot number 221451509 on the device packaging or label. The product includes the GTIN 00763000082987 and has a use-by date of 2022-10-28.
Look for the lot number 221451509 on the device packaging or label.
The specific lot number for this recall is 221451509.
The product was supposed to be used by October 28, 2022.
The recall notice 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-1886-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1886-2021 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.
