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LivaNova USA Inc recalls VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in pati
Recalled December 16, 2020 · FDA recall Z-0535-2021 · LivaNova USA
Hazard
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. · FDA Class II
Units
8 generators
Sold at
International distribution in the countries of Austria and United Kingdom.
Description
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Product
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.
Manufacturer(s)
LivaNova USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →