Recall Z-0936-2021 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
| Date | Dec 2, 2020 |
| Status | Open, Classified |
| Reason | Accelerated battery depletion may result in a need for device replacement earlier than expected. |
| Root cause | Process change control |
| Action | The firm issued an Important Medical Device Advisory beginning on 12/02/2020 to its field representatives and implanting surgeons by letter; The notice explained the issue and provided recommendations for the surgeons and referred the surgeons with additional questions, or to report a clinical event, to their Boston Scientific representative or Technical Services. Patients were also notified of the issue and provided them with the website and instructions on how to confirm whether his/her implant was part of the affected groups. |
| Quantity | 11296 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.