The FDA slapped CareFusion Corp.’s (NYSE:CFN) EnVe ventilator recall with Class I status over concerns that glitches in the device may lead to serious neurological injury or death from insufficient ventilation.
The company reported that certain EnVe ventilators may switch from an operational state to a reset state and the ventilator may become disconnected from its port during transport. In addition, if the ventilation mask is removed from a patient momentarily and placed back, the flow may not immediately resume.
CareFusion initiated a recall last month after it identified the potential risks in EnVe models manufactured between December 2010 and May 2011.
The FDA bumped the recall up to Class I, reserved for device issues with a reasonable probability of serious adverse health consequences, because a failure to properly ventilate a patient may lead to neurological injury or death.
CareFusion launched the EnVe ventilators in the U.S. in the first quarter 2009. The product line underwent a Class II recall in February 2010 because the devices didn’t fully meet standards for electromagnetic interference immunity.
The San Diego-based company noted that the recall doesn’t affect current production or shipping processes.