Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated Recalled by LivaNova USA Inc Due to During internal testing, it was found that upon...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA Inc directly.
Affected Products
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Quantity: 8 generators
Why Was This Recalled?
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Where Was This Sold?
International distribution in the countries of Austria and United Kingdom.
About LivaNova USA Inc
LivaNova USA Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report