# FDA recall Z-2255-2018

> **Cyberonics, Inc** · Class II · device recall initiated 2017-11-13.

## 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

- **Recall number:** Z-2255-2018
- **Recalling firm:** Cyberonics, Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2255-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2255-2018. Source: US FDA. Licensed CC0.

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