Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - 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. has recalled one Mosaic 310 Bioprosthesis heart valve (Serial Number B804937, GTIN: 00643169594869) that was mislabeled with an incorrect size. The actual surgical heart valve is larger than what was indicated on the box and jar labels. This device was part of a group of fifteen affected units distributed worldwide to locations including the United States (Tennessee, New York, and New Jersey) and several European countries (France, Italy, Poland, and Spain).
The mislabeling creates a risk that surgeons could implant a valve that does not match the patient's anatomical requirements. The source document does not specify what actions affected consumers should take in response to this recall.
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: 00643169594869 Serial Number: B804937
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.