LivaNova recalls SenTiva VNS generators (serial numbers <500,000) that may stop delivering nerve stimulation, risking seizure return or surgery. Affected users should contact for replacement.
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 VNS therapy generators with serial numbers below 500,000. These devices may stop working properly, causing seizures to return or requiring surgery to replace the device.
The generator's internal component can become stuck, stopping nerve stimulation. This may cause seizures to return or require surgery to replace the device later.
Patients using the SenTiva VNS therapy system for seizure or depression treatment are affected. Those with serial numbers below 500,000 are most at risk.
Check the serial number on your SenTiva generator. Affected units have serial numbers less than 500,000.
Look for the serial number on your SenTiva generator. Affected units have serial numbers less than 500,000.
Reach out to LivaNova for a replacement generator or other assistance.
No, but you should check your serial number and contact LivaNova for a replacement if it's below 500,000.
The generator may stop delivering stimulation, causing seizures to return or requiring surgery to replace the device.
Check the serial number on your generator. Affected units have serial 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-1073-2025 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1073-2025 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.
