Boston Scientific Corporation Recall 92760
Description: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Boston Scientific Corporation Recall 92760 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2441-2023 |
| Event ID | 92760 |
| Event Description | EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 3,856 units |
| Recall Reason | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval. |
| Device Classification | 20230830 |
| Device Code Info | GTIN: 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002; All EMBLEM S-ICDs enrolled in LATITUDE |
| Center Classification Date | 20230822 |
| Recall Initiation Date | 20230711 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
| Similar To |