Implantable VNS Therapy Generators May Stop Delivering Treatment
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
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 a Class II medical device recall affecting implanted neural stimulators used for seizure management. The product is a risk-of-harm device, and while no illnesses or injuries are reported in the source, the potential for therapy cessation in patients dependent on continuous seizure control poses significant clinical risk.
Plain-English summary
LivaNova USA, Inc. is recalling approximately 8,223 units of the SenTiva VNS Therapy System, Model 1000, which consists of an implantable pulse generator, lead, and external programming system. The device delivers electrical stimulation to the vagus nerve to manage seizures.
A potential internal component issue has been identified that may cause the implanted pulse generator to stop delivering therapy. The source material does not specify which component is affected or under what conditions the failure occurs, only that there is potential for therapy cessation due to this internal issue.
The recalled units were distributed worldwide, including throughout the United States. Patients who have received one of the affected generators should contact their treating physician or LivaNova to determine whether their device is among the recalled lot numbers and to discuss appropriate next steps.
Patients should not discontinue use of their devices without consulting their healthcare provider, as abrupt cessation of therapy could result in unmanaged seizures. Healthcare providers should verify whether their patients' implanted devices are affected and arrange for device inspection, reprogramming, or replacement as clinically indicated.
The recalled product
- Product
- Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
- Manufacturer
- LivaNova USA, Inc.
- Hazard
- device-failure
- loss-of-efficacy
Distribution
Distributed nationwide across the United States.
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