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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy AspireHC Pulse Generator

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  Class 2 Device Recall VNS Therapy AspireHC Pulse Generator see related information
Date Initiated by Firm November 20, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on February 08, 2016
Recall Number Z-0858-2015
Recall Event ID 69844
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings.

Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Code Information Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
281-228-7200
Manufacturer Reason
for Recall		 The recalled product was distributed with an incorrect serial number printed on the device's label.
FDA Determined
Cause 2		 Labeling mix-ups
Action The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.
Quantity in Commerce 1 unit
Distribution Distributed to PA.
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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