On June 24, 2005, Guidant Corp. said it advised doctors to stop implanting some of its defibrillators, which U.S. regulators may recall. Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs.

The devices are designed to protect patients from life-threatening heart rhythms, but a number of them have been subject to a component failure that may limit available therapy. Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. Four incidents have been confirmed out of about 46,000 devices; a fifth is suspected but cannot be confirmed, the company said.

In the four occurrences in which the device was implanted, the device sounded a warning that alerted patients or their physicians of the defect, and the devices were replaced. One other incident occurred in a device before it was implanted. Guidant said it would establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices.

On July 1, 2005 the FDA issued the following update concerning the recalls:

FDA Updates Consumers on Guidant Implantable Defibrillators

As the Food and Drug Administration (FDA) continues to evaluate the safety and performance of certain implantable defibrillators manufactured by Guidant Corporation, the Agency has now classified the recalled devices. This additional information on the relative health risks of the devices will help patients and doctors take appropriate action, if necessary.

Classifications can fall into three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects.

"Malfunctions in these devices can lead to serious consequences and it's important for patients to call their doctor for additional information and personalized advice," said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health. "However, it's also important to understand that in most cases these defibrillators work well and save lives."

Below is a full list of the 11 devices affected by this recall classification.

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.

Guidant previously informed patients and physicians about the defibrillator problems and has provided additional instructions for safe use of the devices. Guidant's recommendations include:

• If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
• Continue to keep your normal doctor appointments.
• If you feel a shock, contact your doctor as soon as possible.
• If you or others hear "beeping" from your device, go immediately to your doctor or the emergency room.

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.

FDA requests that physicians support Guidant's efforts to acquire additional information about the performance of these devices. Specifically, FDA asks doctors to test these devices at the time they are no longer in service and if possible to return the devices to the manufacturer for analysis.

Guidant Corp. has voluntarily recalled nearly 50,000 of its cardiac defibrillators implanted in patients worldwide because of potential malfunctions in the devices. Implanted defibrillators shock the heart back into a normal rhythm when it starts beating irregularly.

The recall includes about 38,000 devices used by patients in the United States and includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs. The company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use. Guidant stated that the devices could, without warning, develop a short circuit that would prevent them from delivering the shock when needed. There have been reports of at least 45 malfunctions and are thought to have caused several deaths.

Guidant said patients implanted with those devices should continue to see their doctors at three-month intervals and any patient who recently received a defibrillator shock should consult with their physician. The FDA has said that a patient who feels an electrical shock from the heart devices should call his or her doctor immediately. Patients who hear a "beeping" from a device should contact their doctors immediately or go to the nearest emergency room, according to the FDA.

If you or a loved one received a Guidant heart device, please complete our online form or call us at 1-800-448-5800.

Guidant has warned physicians about potential problems in nine models of pacemakers made between 1997 and 2000. Guidant says a seal is slowly degrading the pacemakers which may result in serious health complications. Guidant has identified 69 device failures and has received reports that several patients have lost consciousness or developed possible heart failure. About 28,000 of the pacemakers remain implanted worldwide. Guidant warns patients to seek immediate medical attention if they have shortness of breath, dizziness, lightheadedness or a prolonged, fast heart rate. Guidant has also advised that physicians should consider replacing the pacemakers.

On June 12, 2003, Endovascular Technologies Inc. a subsidiary of Guidant Corp. one of the nation's largest medical device manufacturers, pleaded guilty to 10 felonies, admitting that it made false statements to the government and hid thousands of serious health problems, including 12 deaths, caused by the company's Ancure stent graft, a heart device used during operations to treat aneurysms. The company agreed to pay $92.4 million in civil and criminal penalties to settle the federal charges. The settlement represents the largest amount ever paid by a medical devices maker for failure to report problems to the Food and Drug Administration (FDA), and is also one of the first times there have been felony convictions in such cases.

According to court documents, federal prosecutors said the device often malfunctioned and that company sales representative asked doctors to use it in ways not approved by the government. Charges brought by the government stated that soon after the product entered the market, doctors and others began to report to the company malfunctions with the stent graft's delivery system, resulting in its becoming lodged in the body of the patient. As a result, doctors were forced to perform surgery to remove the delivery system. Faced with these problems, sales representatives, who were often present when the procedure was performed, began telling doctors to break off the handle of the delivery system if it became stuck and extract it in pieces. The charges say that solution was devised in part by the sales representatives, with no testing to prove the procedure was safe or effective.

United States Attorney, Kevin Ryan called the company's actions "criminal", stating, "because of the company's conduct, thousands of patients underwent surgeries without knowing the risks they faced, and their doctors - through no fault of their own - were unprepared to deal with those risks." Federal prosecutors have stated they are considering bringing criminal charges against company executives.

The company's guilty plea prompted the onset of class action lawsuits filed against the company on behalf of its shareholders. On June 16, Guidant announced that it would discontinue production of the Ancure heart stent and shut down manufacturer Endovascular Technologies.

If you or a loved one received a Guidant heart device, you may confidentially complete our online claim form. We will respond to your inquiry at no cost or obligation within one business day.

If you or a loved one have suffered an injury or experienced serious side effects after receiving a heart device, please complete our FORM or CALL 1-800-448-5800