Recall Z-0561-2020— LivaNova USA Inc
Class I · Terminated
Class I FDA medical device recall by LivaNova USA Inc, initiated 2019-08-22, terminated 2024-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy. Reason: Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-08-22
- Terminated
- 2024-03-28
- Firm location
- Houston, TX, United States
Product description
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Reason for recall
Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.