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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy Generator

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  Class 2 Device Recall VNS Therapy Generator see related information
Date Initiated by Firm March 06, 2015
Date Posted April 27, 2015
Recall Status1 Terminated 3 on October 09, 2015
Recall Number Z-1526-2015
Recall Event ID 70804
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Code Information Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact US Clinical Tech Support
866-882-8804
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.
Quantity in Commerce 13 units
Distribution AR, TX, GA, CA, MI, IN, FL, AZ, NV
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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