Events

Recall of Device Recall VNS Therapy System Generator

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
    47442
  • Event Risk Class
    Class 3
  • Event Number
    Z-0995-2009
  • Event Initiated Date
    2008-02-07
  • Event Date Posted
    2009-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69509
  • 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
    implantable vagus nerve stimulator - Product Code LYJ
  • Reason
    Reset/disabling of the vns therapy demipulse generator and demipulse duo generator due to magnet interference, resulting in the loss of stimulation.
  • Action
    Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered). Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician. If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.

Device

Device Recall VNS Therapy System Generator
  • Model / Serial
    All lots.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.
  • Product Description
    Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.
  • 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