Cyberonics, Inc recalls VNS Therapy Programmer, Model 3000, v1.0 System

Recall date

November 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2255-2018

FDA classification

Class II

Brand / firm

Cyberonics, Inc

Sold / distributed

AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VNS Therapy Programmer, Model 3000, v1.0 System