LivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error
LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.
What this means for you
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a deviation from quality specifications (extra sterilization cycle) without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units. The recall was initiated because the firm identified that these specific generators were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
The affected units are distributed in the United States in the states of Florida, Georgia, Kansas, Missouri, and Utah. There is no distribution outside the United States. The recall includes specific labeling documents associated with the Model 1000 Generator, including sample labels, patient manuals for depression and epilepsy, and the VNS Therapy System Physician's Manual.
Consumers and healthcare providers should contact LivaNova USA Inc for instructions on how to handle the affected devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
- Manufacturer
- LivaNova USA Inc
- Hazard
- Affected units
- 6
Distribution
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