VNS — Class II medical device recall Z-0555-2018
Terminated recall by Cyberonics, Inc, reported 2018-02-14, distributed in CO, ND. Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
| Recall number | Z-0555-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2017-12-02 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-08-06 |
| Distributed | CO, ND |
| Quantity | 2 units |
| Reason classes | software |
| Model numbers | 10-0011-0500, 3000, V1.0.2.2 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0555-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.