Recall Z-1882-2019 ยท DYE Replacement Heart-Valve
Medtronic Inc
Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
| Date | Jun 26, 2019 (initiated May 21, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | The firm initiated the recall by telephone on 05/21/2019 and followed with a letter disseminated on 06/05/2019 which requested that the consignee quarantine any unused affected product and return it to Medtronic. |
| Quantity | 5 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.