Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87662
Description: CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87662 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1528-2021 |
| Event ID | 87662 |
| Event Description | CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 16,311 units |
| Recall Reason | A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted. |
| Device Classification | 20210512 |
| Device Code Info | all codes |
| Center Classification Date | 20210504 |
| Recall Initiation Date | 20210406 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
| Similar To |