The US Food and Drug Administration (FDA) has tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as Class I.
Although there have been no injuries or deaths reported due to the device issues, Class I indicates that continued use of the recalled products, without actions being taken, could cause serious injury or death. Class I is the most serious designation for a recall issued by the FDA.
Go deeper with GlobalData
The recall affects Phasitron breathing circuit kits used for continuous, controlled ventilation of patients who are unable to breathe on their own. The device has a venturi component that helps with the pulsing of air. The venturi effect is used in various respiratory medical devices to help oxygen flow to the patient.
A customer complained that the venturi component of the kit stopped moving during use, which caused a patient’s oxygen levels to fall. The FDA stated that along with a lack of oxygen – respiratory failure, carbon dioxide buildup in the blood, and potential brain damage are other health consequences that could occur with continued use of the device. Heart complications, increased risk of pneumonia, and death are also possible, the agency commented in the recall alert.
The FDA stated that the risk of the venturi component’s failure is especially high for paediatric patients due to low pressures.
The Phasitron breathing circuits were originally developed by US company Percussionaire, a company that was then acquired by Switzerland-headquartered Sentec in September 2022.
Sentec did not immediately respond to Medical Device Network when asked about the recall designation.
Five product lines are affected by the issue, with a total of 30 lot numbers potentially affected. As per the FDA’s recall database, there are 4,727 packs/cases currently in circulation in the US.
Sentec/Percussionaire sent all affected customers an Urgent Medical Device Notification in December 2024. The letter detailed recommendations that included monitoring the venturi component and reviewing the inventory for affected lot numbers, among other actions.
This is not the first time the companies have been in trouble with the FDA. The Phasitron breathing circuits were subject to a Class I recall in November 2024, after reports of the unexpected presence of nickel coating on one of the device’s components.
In May 2023, device giant Draeger encountered problems with its breathing circuit kits due to loose components arising from manufacturing errors. The company recalled more than half a million devices due to the issue, which was tagged as Class I by the FDA.
