LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000 that may stop delivering therapy, risking seizure return or surgery.
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000. These devices may stop delivering therapy, causing patients to return to seizure frequency or depressive symptoms and potentially requiring surgery.
The generators have a component that can become stuck in a closed position, stopping therapy delivery. This may cause patients to return to their seizure frequency or depressive symptoms, and could eventually require surgery to replace the device.
Patients using LivaNova's SenTiva or SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000 are affected. Those with epilepsy or depression who rely on the device for treatment are most at risk.
Check the serial number on your generator. The recalled units have serial numbers less than 500,000. These devices are part of the VNS therapy system for vagus nerve stimulation.
Look for the serial number on your generator; recalled units have numbers less than 500,000.
Reach out to LivaNova for guidance on next steps if your device is affected.
LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000 that may stop delivering therapy.
The generators may stop delivering therapy due to a stuck component, causing patients to return to seizure frequency or depressive symptoms and potentially requiring surgery.
Check the serial number on your generator; recalled units have numbers less than 500,000.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1072-2025 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1072-2025 from LivaNova. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
