Recall Z-1526-2015— Cyberonics, Inc
Class II · Terminated
Class II FDA medical device recall by Cyberonics, Inc, initiated 2015-03-06, terminated 2015-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.. Reason: The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture..
- Recalling firm
- Cyberonics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-06
- Terminated
- 2015-10-09
- Firm location
- Houston, TX, United States
Product description
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Reason for recall
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
Data sourced from openFDA. This site is unofficial and independent of the FDA.