LivaNova recalls SenTiva DUO VNS Therapy generators (Model 1000-D) that may stop delivering nerve stimulation therapy due to internal component issues. Affected units were sold starting May 13, 2020.
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
LivaNova is recalling SenTiva DUO VNS Therapy generators (Model 1000-D) that could stop delivering nerve stimulation therapy because of an internal component issue. This means the device might not work properly, which could affect the treatment for conditions like epilepsy or depression.
The implanted pulse generator in the VNS Therapy system may stop delivering electrical signals to the vagus nerve due to an internal component issue. This could cause the therapy to stop working, which might affect the treatment for conditions like epilepsy or depression.
People with a SenTiva DUO VNS Therapy generator implanted under their skin are affected. Those who have the specific Model 1000-D generator are most at risk.
Check if your device has the Model 1000-D generator with serial numbers starting from 324841 to 340589. The product was sold starting May 13, 2020.
Verify if your generator has the Model 1000-D with serial numbers from 324841 to 340589.
Talk to your physician about whether your device needs to be replaced or repaired.
Yes, this recall affects people with the SenTiva DUO VNS Therapy generator (Model 1000-D) that was implanted starting May 13, 2020.
Check if your generator has the Model 1000-D with serial numbers from 324841 to 340589.
No, but you should contact your doctor to check if your device needs to be replaced or repaired.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1068-2025 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1068-2025 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.
