Recall Z-0645-2016— Cyberonics, Inc
Class II · Terminated
Class II FDA medical device recall by Cyberonics, Inc, initiated 2015-11-18, terminated 2017-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Cyberonics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-18
- Terminated
- 2017-09-06
- Firm location
- Houston, TX, United States
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.
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