Source: FDA.govLivaNova has issued a recall of its product, VNS Therapy SenTiva Generator System, model 1000. The device is used for vagus nerve stimulation therapy to reduce the frequency of seizures associated with epilepsy in patients over four years old and to treat major depressive episodes in patients 18 and older. The FDA has categorized this as a Class I recall, the most serious type, because use of the device may cause serious injury or death.

The devices being recalled were distributed pre-screen from April 19 to Sept. 30, 2019, and post-screen beginning July 31, 2019.

According to the FDA, the SenTiva Generator System includes an implantable VNS therapy generator with a lead and electrodes around the vagus nerve, the body's main parasympathetic nerve. Healthcare providers change stimulation settings with an external programming system. The device detects increases in heart rate that could signal seizures or depressive episodes and responds by sending mild pulses to the brain via the vagus nerve.

The company initiated the recall following reports of unintended reset errors. The errors can cause the device to stop delivering VNS therapy. No deaths related to this have been reported, but LivaNova has received 14 reports of reset errors and four patients have required surgery for failed devices. Replacement of the device incurs risks associated with the required surgery.

LivaNova implemented additional mitigations on July 31, 2019, and although these mitigations are under review by the FDA, no reset errors have been observed since their implementation.

Hospitals and healthcare providers of patients with the implanted VNS Therapy SenTiva Generator System were notified of the recall on Aug. 23 and 26, 2019, with a follow-up notification on Oct. 8, 2019.

Information on the steps healthcare providers and patients should take regarding this device can be found at FDA.gov.