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FDA Designates Vyaire Dual Tube Product Recall as Class I

Posted on by darion

This is the second class I remember this year for Vyaire. Image source: Shutterstock/Tada images.

Vyaire Medical was already certified as a Class I by the U.S. Food and Drug Administration (FDA) this year, and now the company is once again in a bitter conflict with the agency – this time over tubes for the company’s cardiopulmonary stress test system ( CPET).

Vyaire Twin Tube Sampling Lines collect gas samples from test subjects using the Vyntus CPX System, a CPET device. The system is equipped with sensors that measure oxygen and carbon dioxide from the patient’s inhalations and exhalations to provide data on lung function. Inside the tube there is a drying hose that protects the gas sensors from moisture as the patient inhales and exhales.

The recall is due to the nozzle separating from the tube and falling into the patient’s mouth. The FDA says it can cause choking and airway obstruction.

A total of 649 U.S. devices sold between January 2015 and June 2023 were recalled.

Although the Class I recall means that continued use of the device could result in serious injury or death, the German company Vyaire has not reported any injuries or deaths. The company asked customers to identify the affected devices and perform a “pull test” to check whether the nozzle is connected.

Vyaire did not immediately respond Medical device network for your comment.

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This is the second class I remember this year for Vyaire. In March, the company recalled more than six and a half million AirLife manual resuscitators due to a manufacturing defect. Vyaire initiated the recall after reports of patients who were not receiving sufficient ventilation, which could result in hypoventilation or hypoxia. A total of 37 incidents were reported, including two injuries and two fatalities.

The beginnings were not easy for the group’s CEO, John Bibb, who was promoted to this position exactly a year ago. Investment firm Apax Global Alpha, which has Vyaire on its books, said it saw a decline in first-quarter 2024 earnings due to the health technology company’s poor performance.