Reported Jan 1, 2020 · Terminated
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
LivaNova USA Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova USA Inc · 100 Cyberonics Blvd · Houston, TX · 77058-2069
Is this the product you have?
- VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
- Lot codes and dates
- Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.
- Amount recalled
- 1687
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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