# FDA recall Z-0555-2018

> **Cyberonics, Inc** · Class II · device recall initiated 2017-12-02.

## Product

VNS(R) Therapy Programmer, GMDN:  44077, Model 3000 v1.0.2.2      Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

## Reason for recall

Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.

## Distribution

US Distribution to the states of : CO and ND

## Key facts

- **Recall number:** Z-0555-2018
- **Recalling firm:** Cyberonics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-02
- **Report date:** 2018-02-14
- **Termination date:** 2018-08-06

- **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-0555-2018

## Citation

> AI Analytics. FDA recall Z-0555-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0555-2018. Source: US FDA. Licensed CC0.

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