LivaNova Recalls VNS Therapy SENTIVA DUO Generators Due to Model Number Error
LivaNova is recalling eight SENTIVA DUO VNS Therapy generators because they display the incorrect model number after a device reset.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a software/interrogation error (incorrect model number display) with no reported injuries or direct physiological harm, fitting the criteria for a moderate severity issue.
Plain-English summary
LivaNova USA Inc is recalling eight units of the VNS Therapy SENTIVA DUO # 1000-D generator. These devices are indicated for the treatment of chronic or recurrent depression in patients experiencing a treatment-resistant or treatment-intolerant depressive episode.
The recall was initiated after internal testing revealed that the generator exhibits the incorrect Model Number when interrogated following a device reset. The affected units were distributed internationally in Austria and the United Kingdom.
Patients and healthcare providers with these specific devices should contact LivaNova USA Inc for further instructions on how to proceed.
The recalled product
- Product
- VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
- Manufacturer
- LivaNova USA Inc
- Hazard
- Affected units
- 8
Distribution
Distribution scope not specified by the agency.
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