FDA designates Class 1 recall for IPV therapy system

Editor's Note

The US Food and Drug Administration (FDA) has deemed the recall of Sentec Percussionaire’s Phasitron 5 In-Line Valve—a component of the manufacturer’s Intrapulmonary Percussive Ventilation (IPV) therapy system—a Class 1, the most severe category indicating serious risk of injury or death.  

According to the agency’s October 2 announcement, the recall was motivated by reports of injuries resulting from failing to remove the blue plug from the expiratory port when applying the therapy directly to a patient’s airway. Failure to remove the cap results in too much pressure from the ventilator and potentially serious health consequences including cardiac arrest, air entering the pneumothorax, tracheobronchial tears, and death. Six injuries and zero deaths have been reported.

To address the problem, the manufacturer is updating use instructions and labeling to advise users to remove the cap on the expiratory port and emphasize that it is a protective cap only, to be placed when therapy is not being provided. During therapy, the expiratory port should remain open.