Recall Z-0951-2021 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
EMBLEM MRI S-ICD Model A219
| Date | Feb 5, 2021 (initiated Dec 2, 2020) |
| Status | Terminated |
| Reason | Electrical overstress may lead to device malfunction. |
| Root cause | Process control |
| Action | Boston Scientific will communicate worldwide to physician customers via a customer letter. The customers notified will be as follows: " EMBLEM S-ICD implanting physicians/centers and/or following physicians/centers of record for the advisory population. Physicians associated with an advisory device will receive a list of affected model/serials for patients which they have implanted and/or followed or sent to their center. Boston Scientific will deliver the notification by hand or email via our sales representatives or deliver the letter via Federal Express, Courier, or email. Boston Scientific |
| Quantity | 872 units |
| Distribution | Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.