Recall Z-0879-2021 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
| Date | Jan 19, 2021 (initiated Nov 13, 2020) |
| Status | Terminated |
| Reason | There is potential for fractures which results in the inability to delivery therapy. |
| Root cause | Device Design |
| Action | Boston Scientific will communicate worldwide to physician customers via a customer letter. The firm notified consignees on December 2, 2020 via customer letter notifications (Dear Healthcare Professional, Dear Healthcare Administrator, and Dear Patient) . The customers notified will be as follows: " EMBLEM Electrode Model 3501 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 |
| Quantity | 47000 units |
| Distribution | Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.