Recall Z-0659-2016— Cyberonics, Inc
Class II · Terminated
Class II FDA medical device recall by Cyberonics, Inc, initiated 2015-12-18, terminated 2017-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.. Reason: Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled..
- Recalling firm
- Cyberonics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-18
- Terminated
- 2017-03-02
- Firm location
- Houston, TX, United States
Product description
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Reason for recall
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.