VNS Therapy¿ AspireHC¿ Generator — Class II medical device recall Z-3020-2017
Terminated recall by Cyberonics, Inc, reported 2017-08-23, distributed nationwide. Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than
| Recall number | Z-3020-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2017-06-13 |
| Classified | 2017-08-11 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2023-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, CA, CZ, DE, FI, GB, HR, IE, IL, IT, JP, LB, NL, NO, PL, QA, SA |
| Quantity | 1,909 units |
| Serial numbers | 34898, 34916, 35981, 36098, 36101, 36103, 36309, 36310, 36312, 36395, 36397, 36399, 36406, 36411, 36415, 36416, 36418, 36427, 36428, 36444, 36445, 36461, 36465, 36466, 36467 and 475 more |
| Model numbers | 106 |
Product
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. 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 refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode
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.
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-3020-2017. 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.