Ventilator Recalled Due To Potential Adverse Health Consequences Including Death

The EnVe Ventilator, intended for continuous breathing support for the care of newborns through adult patients who require mechanical ventilation, was voluntarily recalled. This ventilator is used in hospitals and other health care facilities. The manufacturer sent an "Urgent Product Recall" letter to its customers.


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.


If ventilation resumes after an intermittent leak and the audible alarm stops, the firm directs users to clear the alarm indicator on the ventilator display by entering the Alarm Messages tab and pushing the alarm reset to clear the display. If the ventilator has a continuous leak and normal ventilation does not resume, the firm directs users to provide an alternate method of ventilation to the patient. The firm instructs users to constantly monitor ventilator-dependent patients to ensure that if a malfunction occurs, alternate ventilation can be provided. This product may cause serious adverse health consequences, including death.


This is considered a Class I recall.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.


See the recall