medical Class II Updated 2019-07-03

Medtronic Inc recalls Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product

Recalled Product

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146
View official government recall

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