VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall without reported illnesses or injuries. The hazard is theoretical—described with conditional language ('may stop,' 'may result')—and involves risk of therapy loss. Per the rubric, risk-of-harm medical devices without reported injury score at most 3.
Plain-English summary
The U.S. Food and Drug Administration is recalling the SenTiva and SenTiva Duo vagus nerve stimulation (VNS) generators, manufactured by LivaNova USA, Inc. These devices are implanted to treat epilepsy and depression.
The internal generators may stop delivering electrical stimulation due to an internal mechanical component that can become stuck in a closed position. This failure would prevent the device from delivering the therapy patients depend on.
Approximately 81,606 devices with serial numbers less than 500,000 have been distributed across the United States and internationally. If the device stops working, patients may return to baseline seizure frequency or depressive symptoms, and may require replacement surgery.
Patients with affected devices should contact their physician or LivaNova USA, Inc. to determine whether their device is impacted and discuss appropriate next steps.
The recalled product
- Product
- SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
- Manufacturer
- LivaNova USA, Inc.
- Affected units
- 81,606
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF/UDI-DI: 1000/05425025750405
- 1000-D/05425025750528 All Serial Numbers less than 500
- 000
Distribution
Part of a larger recall action
This product is one of 2 recalled by LivaNova USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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