Medtronic Inc recalls Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage
Recalled Product
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - 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
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