GUIDANT RECALL MODELS As of July 1, 2005, the FDA issued the following notifications on Guidant Devices at issue: PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 Devices- Class I FDA has classified the actions taken by Guidant for some of their defibrillators as Class I recalls. In a Class I recall, there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death. The firm’s investigation determined these devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned. The device does not give any sign of impending failure and there is no test that predicts whether the device will fail. Two deaths associated with these 42,000 affected devices worldwide (20,600 are still implanted) have been reported to FDA. The affected devices are: PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002 CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004 CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004 A Class I recall designation does not necessarily require removal of the defibrillator. These recalls require Guidant to disclose the device malfunction to patients and doctors while providing additional instructions for safe use of the devices. FDA is not making a recommendation on whether patients who have one of these devices should have it removed and replaced. FDA believes that this decision must be made by the patient in consultation with his or her physician, based on the specific medical situation of the patient. Replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision. VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices- Class II FDA has classified the previous actions taken by Guidant for these devices as a Class II recall. For a Class II recall, the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote. These Guidant devices are subject to a memory error which, in rare cases, may limit available therapy. Of the 21,000 devices implanted worldwide (18,000 in the U.S.), two incidents have been confirmed, neither of which resulted in death or injury. The defect can be detected by medical evaluation of the device and Guidant is recommending the device be reprogrammed during the patient’s next doctor visit. Guidant is developing an additional non-invasive software solution for this problem, which is expected by the end of the year. CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices- Class II FDA has classified the previous actions taken by Guidant regarding these devices as a Class II recall. These devices are subject to a component failure that in rare cases may limit available therapy. A magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device’s ability to treat ventricular or atrial tachyarrhythmias (abnormally fast heart rhythms) and also accelerates battery depletion. Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. In the four confirmed cases, patients and/or physicians were alerted to the condition by audible device tones signaling that the magnetic switch was closed. Based on this information, it is important that patients who hear tones from their device immediately contact their physician or go to the hospital emergency room. As a precautionary measure, Guidant has recommended that physicians discontinue implanting these devices until further notice. For devices already implanted, Guidant has recommended that physicians change “Enable Magnet Use” to “OFF.” This will ensure appropriate therapy to treat the patient’s abnormally fast heart rhythm. Below is a summary of the Guidant Model Numbers at issue: CONTAK RENEWAL (Model H135) CONTAK RENEWAL (Model H155) CONTAK RENEWAL 3 (Model H170, H173, H175) CONTAK RENEWAL 3 AVT HE (Model M157, M159) CONTAK RENEWAL 3 AVT (Model H150, H155) CONTAK RENEWAL 3 HE (Model H177, H179) CONTAK RENEWAL 4 (Model H190, H195) CONTAK RENEWAL 4 AVT HE (Model H177, H179) CONTAK RENEWAL 4 AVT (Model H170, H175) CONTAK RENEWAL 4 HE (Model H197, H199) RENEWAL 3 AVT HE (Model M157, M159) RENEWAL 3 AVT (Model H150, H155) RENEWAL 4 AVT HE (Model M157, M159) RENEWAL 4 AVT (Model H170, H175) RENEWAL RF HE (Model H239) RENEWAL RF (Model H230, H235) VENTAK PRIZM 2 DR (Model 1861) VENTAK PRIZM AVT (Model 1900) VITALITY AVT (Model A135, A155)