FDA Device recall Z-3020-2017
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator by Cyberonics, citing manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3020-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-13 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cyberonics |
| Distribution | US |
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
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Identifiers
| code_info | Serial Number Expiration Date: 34898 6/16/2017 34916 6/16/2017 35981 4/16/2017 36098 4/27/2017 36101 4/16/2017 36…Serial Number Expiration Date: 34898 6/16/2017 34916 6/16/2017 35981 4/16/2017 36098 4/27/2017 36101 4/16/2017 36103 4/16/2017 36309 3/31/2017 36310 3/31/2017 36312 3/31/2017 36395 3/31/2017 36397 3/31/2017 36399 3/31/2017 36406 5/20/2017 36411 5/20/2017 36415 5/20/2017 36416 5/20/2017 36418 5/20/2017 36427 5/20/2017 36428 5/20/2017 36444 3/31/2017 36445 3/31/2017 36461 5/20/2017 36465 5/20/2017 36466 5/20/2017 36467 5/20/2017 36468 5/20/2017 36475 5/20/2017 36491 5/20/2017 36498 5/20/2017 36501 5/26/2017 36502 5/26/2017 36504 5/26/2017 36508 5/26/2017 36512 5/26/2017 36513 5/26/2017 36536 3/31/2017 36538 3/31/2017 36540 3/31/2017 36541 5/20/2017 36542 5/26/2017 36543 5/26/2017 36544 5/26/2017 36545 3/31/2017 36547 3/31/2017 36548 3/31/2017 36549 3/31/2017 36553 3/31/2017 36557 3/31/2017 36559 5/26/2017 36560 3/31/2017 36561 3/31/2017 36562 3/31/2017 36566 3/31/2017 36569 5/26/2017 36570 3/31/2017 36571 3/31/2017 36572 3/31/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3020-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.