FDA Updates Medtronic Xomed’s Recall of Two Types of NIM Endotracheal Tubes to Class 1
The FDA has issued a Class 1 recall, the agency's most serious category, for certain tracheal tubes made by Medtronic.
The agency updated the April 29 recall of Medtronic Xomed’s NIM CONTACT Reinforced EMG Endotracheal Tube and its NIM Standard Reinforced EMG Endotracheal Tube products, to deem it Class 1.
There are 53,029 affected products in the U.S. and 339,260 outside of the U.S., distributed from April 26, 2018, to April 15 of this year, said FDA. Medtronic Xomed reported receiving 15 complaints of obstruction of the tubes during surgery, which has lead to three injuries and two deaths since March 31, 2020.
These tubes are used during surgery to provide an airway for patient ventilation, but also to monitor electromyogram activity and the nerve integrity of the thyroarytenoid muscle of the larynx. If the tube obstructs, ventilation failure can occur, which can lead to oxygen deprivation, brain damage or death, the FDA said.