FDA Medical Device Recalls (openFDA)
Cyberonics, Inc: Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
- Recall number
- Z-0280-2016
- Recalling firm
- Cyberonics, Inc
- Product
- Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
- Status
- Terminated
- Initiated
- 2015-10-07
- Posted
- 2015-11-17
- Terminated
- 2017-09-06
- 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.
- Root cause
- Manufacturing material removal
- Action
- Cyberonics sent written recall notifications beginning October 14, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. The notice also directs customers to contact Cyberonics to schedule additional on-site troubleshooting. The on-site troubleshooting proposed by Cyberonics will utilize a feature included within the Model 250 Version 9.0 Programming Software as an alternate method of verifying heart rate and determining that the appropriate heart beat sensitivity setting is programmed. The Version 9.0 software displays an instantaneous heart rate when the user selects the 'Refresh' feature. This heart rate is measured directly by the generator and displayed on the programmer. For further questions, please call (866) 882-8804.
- Quantity
- 27 units
- Distribution
- US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
- Lot, serial or model codes
- 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
- 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
- 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