Reported Jul 3, 2019 · Terminated
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic…
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc · 710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN · 55432-5603
Is this the product you have?
- Hancock II T510 Bioprosthesis, Mitral
- REF T510C27 - Product UsageReplacement of malfunctioning native or prosthetic aortic and/or mitral valves
- Lot codes and dates
- GTIN00643169027077
- Serial Numbers
B654768B694390B818699B887929B896723B896730B914146
- Amount recalled
- 7 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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