Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - 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 5 Hancock II T510 bioprosthetic mitral valves used to replace malfunctioning heart valves. The devices were mislabeled with incorrect size information on their boxes and jar labels. In all affected cases, the actual surgical heart valves are larger than the sizes indicated on the packaging. The affected devices have serial numbers B167637, B192698, B217347, B217329, and B217330.
These 15 mislabeled devices were distributed worldwide, including in the United States (in Tennessee, New York, and New Jersey) and internationally (in France, Italy, Libya, Poland, and Spain). 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: 5 units Lot/code info: GTIN: 00643169000261 Serial Numbers: B167637, B192698, B217347, B217329, B217330
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.