CareFusion has initiated a Class I recall of all EnVe Ventilators manufactured between December 2010 and May 2011, because potential defects could interrupt ventilation to patients.
The issues with the portable ventilators include a potential delay in resuming ventilation after reconnection, potential automatic reset, and potential disconnection during transport. The problems could lead to hypoxia or hypercarbia, which may result in serious neurological injury or death, according to the FDA.
CareFusion is contacting facilities to coordinate hardware and software updates for affected products. Healthcare professionals and patients are encouraged to report any adverse events related to the product to the FDA.