FDA announces Class 1 recall for Vyaire Medical’s Twin Tube CPX sample lines

Editor's Note

A choking hazard prompted the US Food and Drug Administration (FDA) to designate Vyaire Medical’s recall of Twin Tube sample lines—critical components of the Vyntus CPX system—as Class 1, the most serious category of recall indicating a risk of serious injury or death.

According to the agency’s May 23 announcement, these tubes connect to the dead volume trap (DVT) adapter, allowing for the continuous collection of gas samples from the test subject's breath during Cardiopulmonary Exercise Testing (CPET) measurements. A drying hose removes moisture from gas samples to protect the integrity of oxygen and carbon dioxide sensors housed within the device. Vyaire recalled the devices due to potential of the nozzle separating during use and falling into the patient’s mouth.

There have been no reports of injuries or deaths associated with this issue. In an April 8 Urgent Field Safety Notice, the company advised affected customers to share information with anywhere products may have been forwarded and to test the components' adhesive prior to use.