Events

Recall of Device Recall Dragonfly 2Channel Laryngeal Surface Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neurovision Medical Products 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
    54233
  • Event Risk Class
    Class 2
  • Event Number
    Z-0798-2010
  • Event Initiated Date
    2010-01-11
  • Event Date Posted
    2010-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87916
  • 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, nerve - Product Code ETN
  • Reason
    This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. this is due to migration of the adhesive from one pad to the other creating an electrical short. use of one of these defective electrodes could lead to a failure to monitor. our investigation has c.
  • Action
    URGENT RECALL: Medical Device Letter dated 1/7/10. The letter identified the affected product and provided a list of necessary actions for customers to take. The customers should immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify their customers and notify them at once of this product recall. Their notification to their customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any failure to monitor. Please complete and return the enclosed response form as soon as possible. If you have any questions, call Ryan Rea or Kevin Rea, at 866-815-6999.

Device

Device Recall Dragonfly 2Channel Laryngeal Surface Electrode
  • Model / Serial
    Lot numbers 113008, 054409, 096709
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI)
  • Product Description
    2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) || For use as a Surgical stimulator/locator for recurrent laryngeal nerve.
  • Manufacturer
    Neurovision Medical Products Inc

Manufacturer

Neurovision Medical Products Inc
  • Manufacturer Address
    Neurovision Medical Products Inc, 275 Burnett Ave, Ventura CA 93003
  • Manufacturer Parent Company (2017)
    Neurovision Medical Products Inc
  • Source
    USFDA