LivaNova VNS Therapy Tablet Software Recall for Diagnostic Error
LivaNova is recalling 643 VNS Therapy Program tablets due to a software error that causes incorrect diagnostic tests on specific devices.
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, and the hazard involves a software error leading to incorrect diagnostic data (false high impedance values) rather than a direct physical injury or death.
Plain-English summary
LivaNova USA Inc is recalling 643 units of the VNS Therapy Program (GMDN: 44077, Model # 3000, Version 1.5.2). The recall is initiated due to reports that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices when the output current is greater than 0.5mA.
This software error can result in false high impedance values during patient follow-up. The affected units were distributed across numerous states, including Illinois, Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming.
Patients using the affected VNS Therapy Program tablets should contact their healthcare provider or LivaNova for further instructions regarding the diagnostic error.
The recalled product
- Product
- VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
- Manufacturer
- LivaNova USA Inc
- Affected units
- 643
Distribution
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