Medtronic recalls Hancock II T510 mitral bioprosthesis devices with mislabeled sizes that could lead to improper valve fitting 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 Hancock II T510 mitral bioprosthesis devices that were mislabeled with incorrect sizes. This could cause improper valve fitting during surgery if the wrong size is used.
The devices were mislabeled with a smaller size than the actual surgical heart valves. This could lead to improper valve fitting during surgery if the wrong size is used.
Surgical patients who received the Hancock II T510 mitral bioprosthesis with mislabeled sizes. Patients who had the device implanted during the specified time frame are most at risk.
Check for the model number T510C27 on the device packaging. The serial number B710405 is also associated with this recall.
Look for the model number T510C27 and serial number B710405 on the device packaging.
The devices were mislabeled with an incorrect size, which could lead to improper valve fitting during surgery.
Check for the model number T510C27 and serial number B710405 on the device packaging.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtr: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-1884-2019 — Medtr: a short, human brand name for headings (e.g. "Trsmima") Medtr: a short, human brand name for Hello, I own a Medtr: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-1884-2019 from Medtr: a short, human brand name for headings (e.g. "Trsmima"). 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.
