Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
FDA device recall Z-0645-2016 · posted 2016-01-13 · Terminated
Recall details
- Recalling firm
- Cyberonics, Inc
- 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.
- 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
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- LYJ
- Quantity affected
- 29 units
- Distribution
- US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
- Date initiated
- 2015-11-18
- Date posted
- 2016-01-13
- Date terminated
- 2017-09-06
- Location
- Houston, TX
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