The U.S. Food and Drug Administration (FDA) announced a Class I recall of endotracheal tubes manufactured by Medtronic Xomed. The September 9 recall states that the use of the Florida-based medical device manufacturer’s products could result in patient death from obstructed airways.
Endotracheal tubes are medical devices that are used during surgery to provide an airway for patients to breathe through as well as monitor any electromyogram activity and nerve integrity of laryngeal muscles. The FDA recall affects over 390,000 of these devices distributed between April 26, 2018, and April 15, 2022. According to the FDA, the recall affects the NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube.
According to the FDA, all lots of the following model numbers have been recalled:
NIM EMG Endotracheal Tube
- REF 8229308, UDI 00643169789548
- REF 8229307, UDI 00643169789531
- REF 8229306, UDI, 00643169789524
- REF 8229307J, UDI 00613994415462
- REF 8229308J, UDI 00613994415431
- REF 8229306J, UDI 00613994415455
NIM CONTACT EMG Endotracheal Tube
- REF 8229508, UDI 00643169789579
- REF 8229507, UDI 00643169789562
- REF 8229506, UDI 00643169789555
These devices are being recalled after reports arose that the NIM CONTACT reinforced EMG endotracheal tube and the NIM standard reinforced EMG endotracheal tube can become obstructed during use. Obstruction of these devices can result in ventilation failure.
If a patient is not ventilated constantly, adverse events can rapidly occur. The most common outcomes of a ventilation failure include oxygen deprivation, brain damage, and death. As of the time of the recall, the FDA states that Medtronic Xomed has reported 15 complaints, 3 injury reports, and 2 deaths associated with the use of the devices between March 31, 2020, and March 31, 2022.
In late April, Medtronic Xomed issued a device correction in order to address the issues with the endotracheal tubes. In this letter, Medtronic made several suggestions for best practices, including urging close adherence to the instructions for use and avoidance of overinflation of the silicone cuff. Medtronic also included instructions for what to do in the event of a ventilation failure. Nonetheless, the FDA issued the class I recall five months later.