Class 2 Device Recall VNS Therapy Generator

• Date Initiated by Firm: March 06, 2015
• Date Posted: April 27, 2015
• Recall Status: Terminated 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: 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.