CareFusion (NYSE:CFN) issued an update on the recall of its AVEA ventilators after receiving 5 complaints from a clinical providing neonatal care. No injuries have yet been directly attributed to the issues with the ventilators, CareFusion noted.
CareFusion announced the recall early last month, affecting all AVEA ventilators, over issues with the barometric pressure sensor. The device maker warned that the ventilators may under-report tidal volume when used in conjunction with the neonatal hotwire flow sensor, especially at facilities at higher elevations.
"While all AVEA ventilators fall under this voluntary recall, hospitals in locations at high elevations (higher than 5,000 feet above sea level) that are using the AVEA ventilator in the neonatal patient care setting are at greatest risk of this error," according to the CareFusion notice. "CareFusion has received 5 complaints from a facility that was operating in the neonatal patient care settings and was located higher than 5,000 feet above sea level."
The FDA has been notified of the recall, giving the measure its highest-risk Class I label for its potential to cause injury or death.
CareFusion is not asking clinics to return the ventilators, but warned clinics at higher than 5,000 feet above sea level to stop using the neonatal hotwire flow sensor until a software correction can be implemented.
This latest recall is not the 1st for the AVEA line, which was in 2011 the subject of a Class I recall over a potential failure in the safety valves that could result in failed ventilation. That issue spurred nearly 100 incident reports, but no deaths were associated with the issue.
CFN shares were modestly up today, trading at a 0.2% increase at $36.98 as of about 2:10 p.m.