An FDA evaluation of the five Guidant defibrillators pulled from the market last month will take weeks not months. Guidant pulled the five defibrillators off the market after safety concerns arose. Daniel Schultz, director of the Center for Devices and Radiological Health, said it is up to patients and doctors to determine a course of action in cases where the devices have already been implanted in patients. Some of the deviced affected have been designated “Class I” by the FDA, meaning they have the highest priority recall, while others have been given a “Class II” designation. Class I means that there is a reasonable probability that the malfunctioning device could cause death or major adverse health consequences. The devices given Class I designation are Guidant’s Ventak Prizm 2 DR and Guidant’s Contak Renewal 1 and 2 devices. In other words three of the five Guidant defibrillators have a reasonable probability to cause death or very serious health problems.