CareFusion AVEA Ventilator Recall Issued Due to Risk of Failure

After receiving nearly a hundred reports of malfunctions, CareFusion has recalled its AVEA Ventilator from the market. 

The FDA announced the CareFusion AVEA ventilator recall on December 23, indicating that a defective alarm may actually shut the ventilator down.

Due to the seriousness of the malfunction, the FDA has classified the action as a Class I medical device recall, which is the most serious classification. A Class I recall indicates that the FDA believes the device has a high chance of causing serious injury or death.

According to the FDA, the AVEA ventilator has been reported to activate a false, extended high peak alarm, which then opens the safety valve and stops ventilating.

The problem could injure or kill a patient without a health care professional’s intervention. Although there have been no reported injuries or deaths associated with the product so far, CareFusion has received at least 94 reports of incidents where the ventilators stopped working.

CareFusion sent out letters to customers in September, but the FDA did not become aware of the situation until recently, resulting in the Class I recall.

The recall affects all models of the CareFusion AVEA ventilator manufactured between March 1, 2009 and June 30, 2011, as well as any AVEA ventilators serviced with affected parts during that time period.

The company sent out letters to all affected customers and contacted them by telephone to coordinate corrective actions.

The FDA has called for any health care professionals or patients who have experienced problems due to this device to contact the FDA MedWatch Adverse Event Reporting program at www.fda.gov/medwatch or by calling (800) FDA-1088.