Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - 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 Hancock II T510 Bioprosthesis (mitral valve, model REF T510C27, Serial Number B710405) that was distributed worldwide. The device is mislabeled with an incorrect size on both the box and jar labels. The actual surgical heart valve is larger than the size indicated on the packaging. This device is used for replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
The affected device was distributed to locations in the United States (Tennessee, New York, and New Jersey) and internationally (France, Italy, Libya, Poland, and Spain). The source document does not specify a remedy or corrective 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: 00643169594425 Serial Number: B710405
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.