VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.
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 medical device with mechanically-based failure mode that eliminates critical therapeutic function. No hospitalizations or injuries reported, but device failure would result in loss of seizure control or depression management, potentially necessitating surgical intervention.
Plain-English summary
LivaNova USA, Inc. is recalling the SenTiva, REF: 1000C, a vagus nerve stimulation (VNS) therapy generator. The recall involves 48 devices with serial numbers below 500,000, distributed throughout the United States and internationally.
An internal mechanically activated component within the generator may become stuck in a closed position. When this occurs, the device stops delivering stimulation therapy to the patient.
Patients relying on this therapy may experience a return to baseline seizure frequency or depressive symptoms. In the longer term, affected patients may require surgical replacement of the device.
Patients and healthcare providers should contact LivaNova or their medical provider for guidance on affected devices and appropriate clinical actions.
The recalled product
- Product
- SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
- Manufacturer
- LivaNova USA, Inc.
- Affected units
- 48
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 (2)
- UDI-DI: 05425025750405. 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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