FDA Device recall Z-0280-2016
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 by Cyberonics, citing certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0280-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-07 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cyberonics |
| Distribution | CA, CO, FL, GA, IL, IN, KS, KY, MI, NC, NY, OH, OR, PA, TX, UT, WV |
Product
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Reason
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Identifiers
| code_info | Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271…Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780 |
|---|
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-0280-2016%22
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