Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling one Mosaic 310 Bioprosthetic mitral valve (model REF 310C29, Serial Number B743335) that was distributed worldwide. The device was mislabeled with an incorrect size, with the actual surgical heart valve being larger than the size indicated on the box and jar labels. The affected device was distributed in the United States (Tennessee, New York, and New Jersey) and internationally (France, Italy, Libya, Poland, and Spain).
This surgical heart valve is used for replacement of malfunctioning native or prosthetic aortic and/or mitral valves. The recall record does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain. Quantity: 1 unit Lot/code info: GTIN: 00643169594852 Serial Number: B743335
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.