Events

Recall of Device Recall NIM TriVantage EMG Endotracheal Tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Xomed, 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
    64631
  • Event Risk Class
    Class 1
  • Event Number
    Z-1420-2013
  • Event Initiated Date
    2013-03-04
  • Event Date Posted
    2013-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116684
  • 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
    In march 2013, medtronic issued a recall of the nim trivantage emg endotracheal tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
  • Action
    The firm, Medtronic Xomed, Inc. sent an "URGENT Product Recall Notification" letter dated March 14, 2013, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to return any affected devices still in their possession per the following procedure: 1. Check inventories for the affected products listed on the enclosed checklist. 2. Fill-in the "quantity on-hand" column on the checklist. 3. Fax checklist to Medtronic ENT at 1-904-296-2386. 4. If you have any of the subject product, contact Medtronic ENT Customer Service at 1-800-874-5797 to arrange for returns and replacement or credit. 5.When returning products, clearly mark the outside of the container Returned Goods Authorization (RGA) number. If you have any questions regarding the subject action or the content of the letter, contact Gabriela Anchondo at 904-279-7550.

Device

Device Recall NIM TriVantage EMG Endotracheal Tube
  • Model / Serial
    Product Catalog Numbers: REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739.  Lot Numbers: 205830052 to 206486732. 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.
  • Product Description
    REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only || The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Manufacturer Address
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA