LivaNova has pulled its SenTiva Generator System, a vagus nerve stimulation device, over risks of resets that cause the therapy to be halted.
The device, which is used to reduce seizure frequency in patients with partial onset seizures who haven’t responded to epilepsy drugs, was subject to a Class I recall when 14 reports of unexpected reset errors were received. Of those, four patients needed early revision surgery.
In total, 2,909 devices were recalled. The company said that it put in place additional measures to fix the issue and has not heard of any reset errors since then.