Medtronic recalls 15 Mosaic 310 Bioprosthesis mitral valves due to mislabeled size causing potential fit issues during surgery.
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 valves that were mislabeled with the wrong size. This could lead to improper fitting during surgery if used without correction.
The valves were mislabeled with an incorrect size, meaning the actual surgical valves are larger than what was shown on the packaging. This could cause improper fitting during surgery if the wrong size is used.
Patients who received the Mosaic 310 Bioprosthesis mitral valve (REF 310C29) during surgery are affected. The risk is low as only 15 devices were distributed worldwide.
Check for the product name 'Mosaic 310 Bioprosthesis, Mitral' with serial number B743335 and GTIN 00643169594852. Only 15 devices were distributed globally.
Check the serial number (B743335) and GTIN (00643169594852) to confirm if the device is affected.
15 devices were distributed worldwide.
The model is Mosaic 310 Bioprosthesis, Mitral (REF 310C29).
The valves were mislabeled with an incorrect size, which could lead to improper fitting during surgery.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1880-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1880-2019 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.
