Sam Brusco, Associate Editor05.24.24
Vyaire Medical’s recall of its Twin Tube in the Vyntus CPX system has been identified as Class I by the U.S. Food and Drug Administration (FDA), the most serious type of recall.
The company recalled the Twin Tube because its nozzle can separate during use on patients. The separated component may fall into the patient’s mouth, causing a potential choking hazard. This can lead to an airway obstruction, requiring intervention to prevent further injury or harm.
Vyaire’s April 8, 2024 Urgent Field Safety Notice urged customers to perform physical inventory inspections to identify and isolate potentially affected devices. A pull-out test should be performed on all current inventory to verify the adhesive is adequate before use.
The recall affects devices distributed from January 1, 2015 to June 30, 2023. The company has not yet received reports of injury or deaths related to the issue.
The tubes connect to the dead volume trap (DVT) adapter, allowing continuous collection of gas samples from the test subject's breath during cardiopulmonary exercise testing measurements. Integrated in 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 in the device, analyze oxygen and carbon dioxide levels throughout the patient's inhalation and exhalation during exercise, providing valuable pulmonary function data.
The company recalled the Twin Tube because its nozzle can separate during use on patients. The separated component may fall into the patient’s mouth, causing a potential choking hazard. This can lead to an airway obstruction, requiring intervention to prevent further injury or harm.
Vyaire’s April 8, 2024 Urgent Field Safety Notice urged customers to perform physical inventory inspections to identify and isolate potentially affected devices. A pull-out test should be performed on all current inventory to verify the adhesive is adequate before use.
The recall affects devices distributed from January 1, 2015 to June 30, 2023. The company has not yet received reports of injury or deaths related to the issue.
More about the Twin Tubes
The Twin Tube sample lines play a central role in the Vyntus CPX system.The tubes connect to the dead volume trap (DVT) adapter, allowing continuous collection of gas samples from the test subject's breath during cardiopulmonary exercise testing measurements. Integrated in 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 in the device, analyze oxygen and carbon dioxide levels throughout the patient's inhalation and exhalation during exercise, providing valuable pulmonary function data.