The FDA yesterday released information on a select recall of CareFusion AVEA Ventilators due to electrical issues which could cause unexpected shutdowns.
The federal watchdog labeled the recall as a Class I, the agency’s most serious classification of recall. Class 1 designations are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The AVEA ventilator is designed to support continuous breathing for infants, children and adults at hospitals and professional health care facilities.
CareFusion is recalling the devices because of a faulty fuse on the ventilator’s alarm board which could cause the device to unexpectedly shut down, according to an FDA release on the recall.
If the ventilator stops operating, patients using the device may not receive necessary oxygen which could lead to serious adverse health consequences or death, the agency said.
The recall affects a total of 501 units distributed in the U.S., with multiple AVEA models and product numbers referenced by the FDA.
CareFusion instructed customers with the devices to identify and remove affected ventilators until the company can provide onsite remediation for the units.