Recall Z-0645-2016
Cyberonics, Inc · initiated November 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Codes / lots: Serial numbers 36602, 37019, 39097, 40311, 40465
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.
FDA-determined cause: Manufacturing material removal
Action taken
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
Details
- Recall number
- Z-0645-2016
- Initiated
- November 18, 2015
- Posted by FDA
- January 13, 2016
- Terminated
- September 6, 2017
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 29 units
- Distribution
- US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
- Recalling firm
- Cyberonics, Inc, Houston, TX