Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS Therapy Programmer Recalled by Cyberonics, Inc Due to Certain Model 3000 programming events can result in...
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 Therapy Programmer, Model 3000, v1.0 System
Quantity: 252
Why Was This Recalled?
Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
Where Was This Sold?
This product was distributed to 21 states: AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MS, MO, NJ, NY, NC, PA, TN, TX, UT, WA, WI
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