CareFusion EnVe Ventilators: Class I Recall - Leak In Patient Breathing Circuit or System
MedSun: Newsletter #75, August 2012

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of CareFusion EnVe Ventilators. A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously. The device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised.

Additional Information:

FDA MedWatch Safety Alert. CareFusion EnVe Ventilators: Class I Recall - Leak In Patient Breathing Circuit or System. July 20, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm312966.htm