Z-0645-2016 Class II Terminated
FDA device recall Z-0645-2016 was initiated by Cyberonics, Inc on November 18, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 6, 2017). Affected quantity: 29 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- November 18, 2015
- Termination Date
- September 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
Product Description
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Reason for Recall
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.
Distribution Pattern
US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Code Information
Serial numbers 36602, 37019, 39097, 40311, 40465