FDA Device recall Z-0858-2015
Cyberonics VNS Therapy AspireHC, Model 105 Generator
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Cyberonics VNS Therapy AspireHC, Model 105 Generator by Cyberonics, citing the recalled product was distributed with an incorrect serial number printed on the device's label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0858-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-20 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cyberonics |
| Distribution | PA |
Product
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Reason
The recalled product was distributed with an incorrect serial number printed on the device's label.
Identifiers
| code_info | Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0858-2015%22
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