LivaNova recalls SenTiva VNS therapy devices with serial numbers >= 100000 that may reset within 60 days, potentially requiring surgery or worsening symptoms.
Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
LivaNova recalls SenTiva VNS therapy devices that could reset and become disabled within 60 days of enabling. This may require additional surgery or cause seizure/depressive symptoms to return.
The SenTiva generator may reset and become disabled within 60 days of enabling. If this happens, patients might need extra surgery or their seizure/depressive symptoms could return to baseline.
Patients with implanted SenTiva VNS therapy devices who received the recalled model. Those with devices that reset frequently are at higher risk.
Check if your SenTiva device has a serial number starting with 100000 or higher. This applies to devices that did not undergo the internal error screen.
Verify if your SenTiva device has a serial number starting with 100000 or higher that did not undergo the internal error screen.
The SenTiva generator may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing seizure/depressive symptoms to return.
If your device has a serial number below 100000 or underwent the internal error screen, it is not affected by this recall.
If the device resets, it may become disabled and require re-enabling by a physician, which could lead to additional surgery or worsening symptoms.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0561-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0561-2020 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.
