FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator

Editor's Note

The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious.

The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy for the reduction of seizures.

LivaNova has received 14 reports of unexpected reset errors. Four patients have required early revision surgery for failed devices. No deaths have been reported.

Pre-screen distribution dates were April 19 to September 30, 2019, and post-screen distribution dates were July 31, 2019 to present.