FDA Medical Device Recalls (openFDA)
Cyberonics, Inc: VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
- Recall number
- Z-1526-2015
- Recalling firm
- Cyberonics, Inc
- Product
- VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
- Status
- Terminated
- Initiated
- 2015-03-06
- Posted
- 2015-04-27
- Terminated
- 2015-10-09
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.
- Quantity
- 13 units
- Distribution
- AR, TX, GA, CA, MI, IN, FL, AZ, NV
- Lot, serial or model codes
- Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYJ
- Firm FEI
- 1000117004
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28