FDA recall Z-2255-2018

Product

VNS Therapy Programmer, Model 3000, v1.0 System

Reason for recall

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).

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-11-13

Report date

2018-06-27

Termination date

2022-10-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2255-2018