Medtronic recalls Hancock II T510 mitral valves with mislabeled sizes. Incorrect labeling may lead to improper valve sizing during surgery. Affected units have specific serial numbers and were distributed globally.
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 valves that were mislabeled with incorrect sizes. This could lead to improper valve sizing during surgery if the wrong size is used.
The valves were mislabeled with an incorrect size, meaning the actual valve size is larger than what was indicated on the packaging. This could lead to improper valve sizing during surgery if the wrong size is used.
Patients who received the Hancock II T510 mitral valve with the specific serial numbers listed in the recall are affected. Surgeons and medical teams using these valves during procedures are at risk.
Check for the specific serial numbers: B167637, B192698, B217347, B217329, B217330. The valves were distributed worldwide and were intended for replacement of malfunctioning heart valves.
Verify if your valve has one of the specific serial numbers listed: B167637, B192698, B217347, B217329, B217330.
The valves were mislabeled with an incorrect size, which could lead to improper valve sizing during surgery if the wrong size is used.
Check for the specific serial numbers: B167637, B192698, B217347, B217329, B217330.
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-1882-2019 — 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-1882-2019 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.
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.
