Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.
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: This is an FDA Class II recall with no reported deaths, hospitalizations, or injuries. The hazard is potential therapeutic failure in an implantable device. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
LivaNova USA, Inc. is recalling the VNS Therapy SenTiva DUO implantable pulse generator (Model 1000-D). This device is implanted to deliver vagus nerve stimulation therapy.
The device may stop delivering therapy due to an internal component issue.
A total of 84 units of the affected Model 1000-D have been distributed worldwide, including throughout the United States. Patients with this device should contact their healthcare provider or LivaNova USA, Inc. for guidance.
The recalled product
- Product
- Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, le
- Manufacturer
- LivaNova USA, Inc.
- Hazard
- device-malfunction
- therapy-failure
Distribution
Distributed nationwide across the United States.
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