# FDA recall Z-3019-2017

> **Cyberonics, Inc** · Class II · device recall initiated 2017-06-13.

## Product

VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator.  Model No. 105.    Product Usage:  United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): 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. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are r

## Reason for recall

Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

## Distribution

Worldwide Distribution - US Nationwide and Puerto Rico and the following states:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico.    Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-3019-2017
- **Recalling firm:** Cyberonics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-13
- **Report date:** 2017-08-23
- **Termination date:** 2023-04-27

- **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-3019-2017

## Citation

> AI Analytics. FDA recall Z-3019-2017. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-3019-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*