Cyberonics Recalls Two VNS Therapy Programmer Units Distributed Before Approval
Cyberonics, Inc. is recalling two VNS Therapy Programmer units that were distributed in error before FDA approval of the specific software version.
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 source text indicates a distribution error prior to approval without any reported injuries, illnesses, or specific safety hazards, fitting the criteria for a voluntary precautionary recall or minor issue.
Plain-English summary
Cyberonics, Inc. is recalling two units of the VNS(R) Therapy Programmer, Model 3000, version 1.0.2.2. The recall was initiated because these specific units were distributed in error prior to the FDA approval of the software version 1.0.2.2.
The affected devices are identified by Part Number 10-0011-0500 and specific serial numbers/UDIs listed in the agency records. The distribution was limited to the United States, specifically to the states of Colorado and North Dakota.
The VNS Therapy System is indicated for use as an adjunctive therapy for epilepsy in patients 4 years of age and older, and for the adjunctive long-term treatment of chronic or recurrent depression in patients 18 years of age or older. Consumers and healthcare providers with these specific units should contact Cyberonics, Inc. for instructions on how to proceed.
The recalled product
- Product
- VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and…
- Manufacturer
- Cyberonics, Inc
- Affected units
- 2
Distribution
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