Tracheostomy tubes are inserted down a patient’s throat to provide an airway. When the tubes are defective or used improperly, patients can stop breathing, go into cardiac arrest, suffer brain damage, or die from a lack of oxygen within minutes.
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A tracheostomy tube (also called a “trach”) is a medical device that props open a hole cut into a patient’s neck when they cannot breathe through the mouth.
There are many types of tracheostomy tubes, but most consist of a neck plate, a hollow piece of tubing (“inner cannula”), and a round tip called an obturator that helps make insertion of the tube easier.
Tracheostomy Tube Recall
In June 2015, the FDA recalled thousands of the Medtronic Covidien Shiley tracheostomy tubes for infants and children. Since November 29, 2012, the tubes were made with a wider-angle bend than standard models.
At least 12 serious patient injuries were reported, including “breathing difficulties that impacted oxygen levels immediately upon tube placement” or serious discomfort when breathing. None of the reports describe permanent impairment.
Click here for recalled products and lot numbers.
Hundreds of Events Reported to FDA
According to the Minneapolis Star-Tribune, hundreds of adverse events involving the Covidien Shiley tubes have been reported since 2012, when it was altered to give it a wider angle. However, Medtronic classified only a small fraction of these as “serious.”
Tracheostomy Injury – Malpractice Claims
Hospitals and nursing homes often insert tracheostomy tubes for patients who require mechanical ventilation. Victims may have the right to file a malpractice lawsuit if there is evidence of harm, such as:
- Using a defective tracheostomy tube
- Incorrect insertion or removal of tracheostomy tube
- Not using a tracheostomy tube when needed
- Bacterial or fungal infection
- Accidental removal of a tracheostomy tube
- Wrongful death
- And more