LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error
LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.
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 hazard is a software compatibility issue rather than a direct physical injury risk, fitting the Moderate category for functional defects without reported harm.
Plain-English summary
LivaNova USA Inc is recalling 134 units of the VNS Therapy AspireSR Generator, an implantable pulse generator. The recall is due to a manufacturing error where an extra digit was inadvertently added to the serial number of a subset of the devices.
This serial number error causes the affected generators to be incompatible with therapy programmers running software version 11.0.4. The devices were distributed in 29 U.S. states and the District of Columbia, as well as in Argentina, Finland, and Peru.
Patients with these specific devices should contact their healthcare provider or LivaNova for instructions on how to proceed. The recall is limited to the specific serial numbers listed in the official FDA notice.
The recalled product
- Product
- VNS Therapy¿ AspireSR¿ Generator
- Manufacturer
- LivaNova USA Inc
- Affected units
- 134
Distribution
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