LivaNova SenTiva VNS Therapy Generators Recalled for Potential Device Reset
LivaNova is recalling SenTiva VNS Therapy generators that may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing a return of symptoms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where the defect leads to cessation of therapy and potential need for additional surgery, but no injuries or deaths are reported in the source text.
Plain-English summary
LivaNova USA Inc is recalling 1,687 SenTiva VNS Therapy generators, Model # 1000, for vagal nerve stimulation therapy. The recall affects implanted devices with serial numbers greater than or equal to 100000 that did not undergo the internal error screen. These devices were distributed across 40 U.S. states and the District of Columbia, as well as 12 foreign countries.
The recall is due to a defect where the generators may reset and become disabled within 60 days of being enabled. While physicians can re-enable the devices, they remain susceptible to further resets. If a device experiences this issue, it may lead to additional surgery for premature replacement of the generator, or patients may return to baseline seizure frequency or depressive symptoms due to the cessation of intended stimulation.
Patients with these implanted devices should contact their physician for evaluation and management of the device status.
The recalled product
- Product
- VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
- Manufacturer
- LivaNova USA Inc
- Affected units
- 1,687
Distribution
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