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U.S. Department of Health and Human Services

Class 2 Device Recall VNS(R) Therapy Programmer

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 Class 2 Device Recall VNS(R) Therapy Programmersee related information
Date Initiated by FirmDecember 02, 2017
Create DateFebruary 08, 2018
Recall Status1 Terminated 3 on August 06, 2018
Recall NumberZ-0555-2018
Recall Event ID 78914
PMA NumberP970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
ProductVNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Code Information Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information ContactJoan Ceasar
281-228-7260
Manufacturer Reason
for Recall		Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
FDA Determined
Cause 2		Employee error
ActionThe units were collected by visit on December 21, 2017 and December 28, 2017 from the physicians. Both programmers have been successfully removed from the customers and no further actions are being proposed. For further questions, please call (281) 228-7260.
Quantity in Commerce2 units
DistributionUS Distribution to the states of : CO and ND
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LYJ
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