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. has recalled 7 Hancock II T510 Bioprosthesis mitral valves used for replacing malfunctioning heart valves. The devices were mislabeled with incorrect sizes on their boxes and jar labels, with the actual surgical valves being larger than indicated. The affected devices were distributed worldwide, including in Tennessee, New York, New Jersey, France, Italy, Libya, Poland, and Spain, and can be identified by GTIN 00643169027077 and specific serial numbers: B654768, B694390, B818699, B887929, B896723, B896730, and B914146.
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: 7 units Lot/code info: GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.