Medtronic recalls 15 Mosaic 310 Bioprosthesis mitral valves due to mislabeled size causing potential surgical errors. Affected units have larger valves than labeled.
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Medtronic is recalling 15 specific heart valve implants because they were mislabeled with the wrong size. This could lead to surgical errors if the actual valve size differs from what was indicated on packaging.
The valves were mislabeled with an incorrect size, meaning the actual surgical heart valves are larger than what was shown on the boxes and jar labels. This could cause surgical errors if the wrong size is used during replacement procedures.
Patients who received the Mosaic 310 Bioprosthesis mitral valve (REF 310C31) during surgery are affected. The risk is low as only 15 units were distributed worldwide.
Check for the Mosaic 310 Bioprosthesis mitral valve (REF 310C31) with serial number B804937. The product was distributed worldwide but only 15 units were affected.
Verify the serial number (B804937) and product reference (REF 310C31) to confirm if your valve is affected.
15 units were distributed worldwide.
The Mosaic 310 Bioprosthesis mitral valve (REF 310C31) with serial number B804937.
The valves were mislabeled with an incorrect size, which could lead to surgical errors if the actual valve size differs from what was indicated on packaging.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1881-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1881-2019 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.
