Events

Recall of Brand name: || NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 || NIM¿ EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 || [All products are packaged one unit per box.]

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
    30357
  • Event Risk Class
    Class 2
  • Event Number
    Z-0310-05
  • Event Initiated Date
    2004-10-29
  • Event Date Posted
    2004-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35726
  • 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
    The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. in one case in germany it was reported that the patient had soreness of the throat and was discharged after four days. in the next case the patient had a tracheal wound. it was not clear what caused the wound.

Device

Brand name: || NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29...
  • Model / Serial
    Product Code: 77 ETN  Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
  • Product Description
    Brand name: || NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 || NIM¿ EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 || [All products are packaged one unit per box.]
  • 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