FDA Device recall Z-0659-2016
VNS Therapy AspireSR Generator Model 106
- FDA Device
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of VNS Therapy AspireSR Generator Model 106 by Cyberonics, citing recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0659-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-18 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cyberonics |
| Distribution | n/a |
Product
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Reason
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Identifiers
| code_info | All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061 |
|---|
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-0659-2016%22
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