Getinge Recalls CardioHelp Emergency Drive

Getinge has recalled its CardioHelp Emergency Drive due to a possible blocking or impairment of the emergency crank. CardioHelp is intended to help oxygenate blood and remove carbon dioxide from it. “It moves blood through a circuit outside the body to support the heart and lungs for up to six hours,” a recall notice says. It is also intended to support the heart and lungs during procedures not requiring cardiopulmonary bypass.

“The emergency drive can become stuck or difficult to turn due to friction being generated in the handle attachment,” the notice says. “The stiff hand crank is caused by a scrounger disc that interferes with the turning of the crank.” The faulty crank handle may prevent clinicians from turning it to drive the pump fast enough to adequately support a patient. If this occurs, the patient will lose adequate hemodynamic support or gas exchange, which could result in ischemia, hypoxia, stroke, or death, it says.