CareFusion Provides Update on Avea Ventilator Class I Recall

BD subsidiary CareFusion issued an update Wednesday on its worldwide voluntary recall initiated April 21 of the Avea ventilator to provide clarification on certain units of the product. The device is intended for continuous breathing support in neonatal through adult patients.

Because of risks that the affected products could cause serious adverse health consequences or death, the FDA has designated the recall as Class I. The company says there are no reports of patient injury or death to date.

CareFusion began the recall after reports of a potential malfunction of Avea’s 5 psi pressure transducer. The reports noted that the ventilators might develop a failure mode over time where the ventilator initiates false extended high peak or circuit occlusion audio and visual alarms, opens the safety valve and arrests ventilation. This could cause hypoxemia or hypercapnia in a patient.

The worldwide recall pertains to ventilators sold from July 1, 2011, to March 15, 2015. The company’s website lists affected models and serial numbers, as well as countries where the devices were marketed. — Jason Scott