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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy Aspire HC Generator and VNS

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  Class 2 Device Recall VNS Therapy Aspire HC Generator and VNS see related information
Date Initiated by Firm August 12, 2011
Date Posted November 18, 2011
Recall Status1 Terminated 3 on August 20, 2012
Recall Number Z-0210-2012
Recall Event ID 59818
PMA Number P970003 
Product Classification Stimulator, autonomous nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy Aspire HC Generator and VNS, Model 105

Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058

For implantation in humans to treat Epilepsy and Depression.
Code Information Model 105, VNS Therapy AspireHC Generator
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Brian Olin, Ph.D.
281-228-7323 Ext. 223
Manufacturer Reason
for Recall		 The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of: Lack or loss of efficacy Pain, inflammation, swelling/edema in the neck area; and/or Patient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com. For questions regarding this recall call 281-228-7323.
Quantity in Commerce 340 units
Distribution Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.
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.
PMA Database PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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