Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS(R) Therapy Programmer Recalled by Cyberonics, Inc Due to Two Model 3000 Programmers were distributed in error...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cyberonics, Inc directly.
Affected Products
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 older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Quantity: 2 units
Why Was This Recalled?
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Where Was This Sold?
This product was distributed to 2 states: CO, ND
About Cyberonics, Inc
Cyberonics, Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report