FDA Enforcement
Class II
Terminated
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Recall: Z-0645-2016
·
Reported January 27, 2016
Enforcement
- Recall Number
- Z-0645-2016
- Event ID
- 72698
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cyberonics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 27, 2016
- Initiation Date
- November 18, 2015
- Classification Date
- January 19, 2016
- Termination Date
- September 6, 2017
- Address
- 100 Cyberonics Blvd, N/A, Houston, TX, 77058-2069, United States
Description
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 the potential for decreased battery longevity.
Code Info
Serial numbers 36602, 37019, 39097, 40311, 40465
Distribution
US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Quantity
29 units