Boston Scientific Corporation Recall 87014
Description: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Boston Scientific Corporation Recall 87014 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0879-2021 |
| Event ID | 87014 |
| Event Description | EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD) |
| Product Type | Devices |
| Distribution | Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region |
| Quantity | 47000 units |
| Recall Reason | There is potential for fractures which results in the inability to delivery therapy. |
| Device Classification | 20210127 |
| Device Code Info | All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication. |
| Center Classification Date | 20210119 |
| Recall Initiation Date | 20201113 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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