FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators

FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected by this notification 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

The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.

"FDA's first priority is patient safety," said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health. "We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians."

FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.

FDA advises patients to take the following steps:

• If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
• Continue to keep your regular doctor appointments.
• If you feel an electrical shock from your device, immediately contact your doctor.
• If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Currently, FDA is evaluating this information.

If you are a physician or a patient who has experienced a problem with any of these defibrillators, please send a report to FDA's MedWatch program and to Guidant. See http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).

Guidant will be posting information for physicians on its web site at www.guidant.com. If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).

####

If you have any questions about your legal rights, please contact us to speak with one of our lawyers. Recognized among the most distinguished law firms in the United States in the Martindale-Hubbell® Bar Register of Pre-eminent Lawyers,™ Janet, Jenner & Suggs, LLC has won record breaking verdicts and settlements through its aggressive advocacy.

Our in-house legal team consists of a physician, five registered nurses, 10 attorneys, and more than 30 staff-members. As one of the nation's premier pharmaceutical liability law firms, we represent consumers nationwide who have been victimized by defective pharmaceutical drugs and medical devices, including Guidant defibrillators.  We have the experience to protect your legal rights and to help you obtain the compensation you deserve.  If you or a loved one has suffered serious side effects from a defective defibrillator, please contact us for an immediate case evaluation.

Many law firms that advertise aggressively on the Internet are actually client brokers who refer virtually all clients to lawyers in other firms and other cities who do the actual work of representing the client. Janet, Jenner & Suggs, LLC, is a traditional law firm that actively represents all of our clients. Robert K. Jenner and Kenneth Suggs, leaders of the pharmaceutical department within the firm, will always be accessible to you. Mr. Jenner and Mr. Suggs, nationally recognized advocates on behalf of victims of defective pharmaceutical products, and their highly experienced team, will always be ready to answer your questions.

We encourage you to contact our lawyers today for an immediate free claim evaluation. You may be eligible to participate in a class action lawsuit on behalf of patients who have been injured, or who have died, due to the serious malfunction of Guidant ICDs. Call 1-888-4-MEDLAW or complete our online claim evaluation form.