Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87654
Description: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87654 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1522-2021 |
| Event ID | 87654 |
| Event Description | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 16,311 devices |
| Recall Reason | There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT). |
| Device Classification | 20210512 |
| Device Code Info | All serial numbers |
| Center Classification Date | 20210430 |
| Recall Initiation Date | 20210406 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
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