FDA Medical Device Recalls (openFDA)
Cyberonics, Inc: Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
- Recall number
- Z-0645-2016
- Recalling firm
- Cyberonics, Inc
- Product
- Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
- Status
- Terminated
- Initiated
- 2015-11-18
- Posted
- 2016-01-13
- Terminated
- 2017-09-06
- Reason
- Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
- Root cause
- Manufacturing material removal
- Action
- Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804
- Quantity
- 29 units
- Distribution
- US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
- Lot, serial or model codes
- Serial numbers 36602, 37019, 39097, 40311, 40465
- 510(k) numbers
- not on file
- PMA numbers
- ["P970003"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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