Recall Z-2112-2017 ยท MRM Defibrillator, Implantable, Dual-Chamber
Sorin Group Italia SRL - CRF
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least o
| Date | Apr 11, 2017 |
| Status | Terminated |
| Reason | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. |
| Root cause | Software design |
| Action | Consignees were notified on 4/11/17 via certified letter to make users aware of the issue and what actions to take to mitigate the potential risk of re-intervention associated with undetected battery depletion. Following and implanting physicians are being instructed to do one of two things: 1. Prior to lead revision: Deactivate the shock therapies to avoid further charging1, Wait 24 hours1, and Re-interrogate the ICD or CRT-D to check the updated battery status. If RRT is reached, initiate a device replacement. Or 2. If it is not possible to wait 24 hours prior to replacing the lead, the |
| Quantity | 3096 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.