Events

Recall of VNS Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cyberonics, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55446
  • Event Risk Class
    Class 2
  • Event Number
    Z-1591-2010
  • Event Initiated Date
    2010-04-06
  • Event Date Posted
    2010-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90873
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
  • Reason
    Battery life projection is inaccurate.
  • Action
    Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic. The issue can also be corrected during the initial implant procedure with the instructions provided. Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.

Device

VNS Therapy System
  • Model / Serial
    Model 103, VNS Therapy Demipulse Generator Model 104, VNS Therapy Demipulse Duo Generator Model 250, Programming System (version 7.0 or 7.1)
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution.
  • Product Description
    VNS Therapy¿ Demipulse¿ Generator, Model 103 and || VNS Therapy Demipulse Duo¿ Generator, Model 104 || VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software
  • Manufacturer
    Cyberonics, Inc

Manufacturer

Cyberonics, Inc
  • Manufacturer Address
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA