FDA Device recall Z-1526-2015
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104 by Cyberonics, citing the pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1526-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-06 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cyberonics |
| Distribution | AR, AZ, CA, FL, GA, IN, MI, NV, TX |
Product
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Reason
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
Identifiers
| code_info | Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1526-2015%22
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