Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS Therapy Programming System Recalled by LivaNova USA Inc Due to Unintended warning message displayed on generators programmed with...
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 LivaNova USA Inc directly.
Affected Products
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Quantity: 243 devices total
Why Was This Recalled?
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Where Was This Sold?
This product was distributed to 16 states: AZ, CA, GA, IL, IN, IA, MO, MT, NY, NC, PA, SD, TN, TX, WA, WI
About LivaNova USA Inc
LivaNova USA Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report