Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

FDA declares Vyaire’s twin tube recall as Class I

Vyaire Medical faces another FDA setback, this time regarding tubes in its cardiopulmonary exercise test (CPET) system, following a prior Class I recall this year. The Twin Tube sample lines, part of the Vyntus CPX system, gather gas samples for analysis, measuring lung function by assessing oxygen and carbon dioxide levels during inhalation and exhalation. The recall is due to nozzles detaching from the tube, posing a choking hazard. About 649 devices distributed in the US from January 2015 to June 2023 are affected. Although classified as Class I, indicating potential for severe injury or death, Vyaire has reported no such incidents. The company urged customers to identify faulty devices and perform a "pull-out test" to confirm nozzle attachment. Vyaire did not respond to Medical Device Network's request for comment. This marks the second Class I recall this year for Vyaire, following the March recall of over six million manual resuscitators due to ventilation issues, resulting in two injuries and two deaths.