Vyaire Medical has recalled their Twin Tube, and the FDA has identified the recall as Class I.
The Twin Tube plays a “central role in the Vyntus CPX system. 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. Integrated within the Twin Tubes is a drying hose, which removes moisture from the gas samples to protect the integrity of the gas sensors. These sensors, housed within the device, analyze oxygen (O2) and carbon dioxide (CO2) levels throughout the patient's inhalation and exhalation during exercise, providing valuable pulmonary (lung) function data.”
The Twin Tube is being recalled because the nozzle may separate during patient use, which could lead to it falling into the patient’s mouth and becoming a choking hazard. As of this writing, there have been “no reports of injuries or deaths associated with this issue.”
