Thousands of defective tracheostomy tubes have been recalled because they can cause breathing difficulties low oxygen. Other life-threatening injuries can occur when trach tubes are used improperly or cause infections.
What is a Tracheostomy Tube?
A tracheostomy is a surgical procedure to cut a hole in a patient’s throat (specifically the windpipe or “trachea”) to provide an airway and remove secretions from the patient’s lungs. A tracheostomy tube (or “trach tube”) is a device inserted in the hole to keep it open.
Covidien Shiley Tracheostomy Tube Recall
Medtronic recalled thousands of Covidien Shiley tracheostomy tubes for infants in children in June 2015 after receiving 12 reports of serious patient injuries.
For exact products recalled and lot numbers, click here.
Some of those serious injuries included “breathing difficulties that impacted oxygen levels immediately upon tube placement” and discomfort when breathing. None of the patients had permanent injuries, although low oxygen can lead to brain damage and death.
In November 2012, Medtronic changed the design to make a wider-angle bend than standard models. Within less than three years, the FDA received hundreds of adverse events — but only a small fraction were deemed “serious,” according to the Minneapolis Star-Tribune.
Tracheostomy Tube Injury – Malpractice Lawsuit
Tracheostomy tubes are widely used in hospitals and nursing homes for patients who cannot breathe on their own and need mechanical ventilation for more than a few weeks. You may qualify to file a malpractice lawsuit if there is evidence of harm, for example:
- Defective tracheostomy tube used on a patient
- Harmful insertion or removal of a tracheostomy tube
- Failure to use a tracheostomy tube when necessary
- Infection (bacterial or fungal)
- Accidentally removing a tube
- Low oxygen leading to brain damage