Medtronic recalls specific lots of Custom Perfusion Systems due to potential insufficient welds. Affected units may have safety risks; contact for return instructions.
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 welds in the device could cause it to fail during use, potentially leading to safety risks. This is a manufacturing defect that may not be immediately noticeable but could become critical under certain conditions.
Patients using the Custom Perfusion System with the specific lot numbers mentioned are most at risk. Healthcare providers who handle these devices should also check for affected units.
Check for the lot number 221238931 on the device packaging or label. The product was sold with the GTIN 00763000387044 and expired by October 17, 2022.
Look for the lot number 221238931 on the device packaging or label to confirm if it is affected.
The affected lot number is 221238931.
The product was sold with an expiration date of October 17, 2022.
The recall record 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-1894-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1894-2021 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.
