FDA Announces Recall of New Class I CPET Devices Due to Choking Risk

The U.S. Food and Drug Administration (FDA) announced that Vyaire Medical has recalled its Vyntus CPX two-tube metabolic cart sample collection lines due to ongoing safety concerns. It is a Class I, which means that, according to the FDA, use of these devices “may cause serious injury or death.”

The Vyntus CPX is a cardiopulmonary exercise testing (CPET) system designed to evaluate gas samples from a patient’s breath while using a treadmill or cycle ergometer. It is designed to collect breath-by-breath data from both adult and pediatric patients and can perform stand-alone 12-lead electrocardiograms when used in conjunction with additional equipment.

The recall concerns ongoing issues with the Vyntus CPX system’s dual tubes, which help assess a patient’s breathing by assessing oxygen and carbon dioxide levels. The tubes have been linked to an increased risk of separation.

“The separated item may fall into the patient’s mouth, causing a potential choking hazard, which may lead to airway obstruction requiring medical intervention to prevent further injury or harm,” according to the advisory provided by the FDA.