Recall of NIM Standard Reinforced EMG Endotracheal Tube

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

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
    RC-2016-RN-00929-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-25
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Medtronic have received reports (reported rate is 0.017%) of emg endotracheal tubes, where the ends of electrode wires at the distal end of the tube have extruded through the wall of the tube, entering the cuff and/or puncturing through the cuff and becoming exposed. four (4) of these complaints involved serious injuries, where an extruded/protruding electrode wire penetrated the tracheal wall or a vocal cord (3 reports overseas); or caused cuff deflation and required re-intubation of the patient (1 report in usa).
  • Action
    The current Instructions for Use (IFU) is in the process of being updated to reinforce the warnings/precautions with information relative to this bending issue. Users are advised to: · Do not excessively bend the EMG tube, particularly at an acute angle (less than 90°). Excessive bending may cause the wire electrodes to protrude through the tube puncturing through the cuff and becoming exposed. This may result in serious injuries where the exposed wire can penetrate the tracheal wall or a vocal cord, or cause cuff deflation which will require re-intubation of the patient. The copy of the updated IFU will be mailed to the customers, as soon as it becomes available. This action has been closed-out on 02/03/2017.

Device

  • Model / Serial
    NIM Standard Reinforced EMG Endotracheal TubeProduct Codes: 8229506, 8229507, 8229508 ARTG Number: 169809
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • 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
    DHTGA