The U.S. Food and Drug Administration has issued a Class I recall, the agency's most serious category, for certain tracheal tubes made by Medtronic.
The surgical endotracheal tubes are used during surgery to provide an airway for patient ventilation and also to monitor electromyogram (EMG) activity. An EMG is a diagnostic procedure to gauge the health of muscles and nerve cells.
Medtronic, with operations based in Fridley, Minnesota, first initiated a recall on April 29 after receiving complaints of the potential for the tubes to deprive the patient of oxygen when overinflated.