LivaNova VNS Therapy System Recall Due to Impedance Measurement Shift
LivaNova is recalling VNS Therapy System generators because a timing change causes reported lead impedance values to be higher than previous models, shifting normal ranges relative to existing thresholds.
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. The hazard involves a diagnostic measurement shift (impedance values) rather than a direct physical injury mechanism, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LivaNova USA Inc is recalling the LivaNova VNS Therapy System, which consists of an implantable VNS Therapy generator, lead, and external programming system. The recall involves 9,282 units of the Model 1000 Generator, which was commercially approved for distribution in the U.S. on October 3, 2017. The affected devices are identified by serial numbers less than 100000.
The recall is issued because lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This discrepancy is due to a change in the timing of when the affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and present in the programming software.
The affected devices were distributed in the United States and in several foreign countries, including Austria, Switzerland, Germany, Denmark, Spain, Finland, the United Kingdom, Italy, the Netherlands, Norway, Portugal, and Sweden. The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers
- Manufacturer
- LivaNova USA Inc
- Hazard
- Affected units
- 9,282
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 (1)
- Serial Numbers Less Than 100000
Distribution
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