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, first initiated a recall on April 29 after receiving complaints of the potential for the tubes to deprive the patient of oxygen when overinflated.
So far, there are 15 complaints — including three injuries and two deaths — associated with the tube malfunctions or misuse between March 31, 2020, and March 31, 2022.
The FDA on Monday elevated the recall to its highest level of concern.
There's a chance the tubes could obstruct a patient's airway, putting a patients at risk of oxygen deprivation, brain damage or even death.
The recall covers two products: the NIM Contact reinforced EMG endotracheal tube and the NIM standard reinforced EMG endotracheal tube. More than 53,000 devices in the U.S. and more than 339,000 outside the U.S. are affected by the recall.
"We are evaluating the details and root cause regarding reports of rare instances of serious adverse events potentially related to certain EMG endotracheal tubes. We expect to know more when we complete our evaluation. We believe the NIM EMG tubes are safe when used according to the instructions for use," said Brett Cromwell, a Medtronic spokesman.
The recalled devices are made its Xomed subsidiary. Medtronic acquired the ear, nose and throat medical device manufacturer in 1999.
In its April recall notice, Medtronic advised anesthesia care providers to avoid overinflating the product's silicone cuff so as to prevent airway obstruction, as well as careful positioning of the tube.
"We are not asking customers to return or replace products," Cromwell said. "Customers should carefully review and follow the product instructions for use and contact Medtronic with any concerns regarding the safe use of our products."
