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U.S. Department of Health and Human Services

Class 2 Device Recall Cyberonics VNS Therapy AspireSR Generator Model 106

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  Class 2 Device Recall Cyberonics VNS Therapy AspireSR Generator Model 106 see related information
Date Initiated by Firm October 07, 2015
Date Posted November 17, 2015
Recall Status1 Terminated 3 on September 06, 2017
Recall Number Z-0280-2016
Recall Event ID 72385
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Code Information Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Clinical Technical Support
866-882-8804
Manufacturer Reason
for Recall		 Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
FDA Determined
Cause 2		 Manufacturing material removal
Action Cyberonics sent written recall notifications beginning October 14, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. The notice also directs customers to contact Cyberonics to schedule additional on-site troubleshooting. The on-site troubleshooting proposed by Cyberonics will utilize a feature included within the Model 250 Version 9.0 Programming Software as an alternate method of verifying heart rate and determining that the appropriate heart beat sensitivity setting is programmed. The Version 9.0 software displays an instantaneous heart rate when the user selects the 'Refresh' feature. This heart rate is measured directly by the generator and displayed on the programmer. For further questions, please call (866) 882-8804.
Quantity in Commerce 27 units
Distribution US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
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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