Short Circuit Risk Prompts FDA to Recall Guidant Defibrillators

News Updates

FDA has notified 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

Guidant has also recently informed the 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.

The Guidant defibrillators are implanted into the chest cavity of patients and are intended to monitor irregularities in heart rhythm (arrhythmia). When functioning properly the units can detect when the heart is beating out of rhythm, and deliver a series of electrical shocks to correct the arrhythmia.

Recalls linked to ICD's are not uncommon. There are approximately 50,000 patients in the United States with one of these recalled defibrillators. Guidant Corp. has said that the devices have malfunctioned at least 45 times, causing two deaths.

While medical technology has helped relieve the suffering of many people, the Institute of Medicine estimates that almost 1.3 million Americans are injured or die as the result of faulty medical products.

If you have one of the recalled Guidant defibrillators, contact your doctor immediately to discuss your medical options. 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.

If you feel an electrical shock from a device, or if there is an audible beeping coming from the device, it may mean the defibrillator is damaged.

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.

Brown & Crouppen’s twenty-five year reputation for success is based on the firm’s commitment to deliver the best possible service to clients while making a real difference in people’s lives. We have represented many victims injured by dangerous drugs, defective medical devices and unsafe implants. We have invested significant effort and resources to hold the manufacturers of hazardous products accountable for the promises they make and the promises they break. Our product liability claims have included prostheses, heart devices (pacemakers and valves), hip replacements and knee replacements.

At Brown & Crouppen our experienced team of lawyers provide tough, aggressive representation for victims and their families. When you choose us to handle your lawsuit, our entire team becomes fully committed to your cause. We’ll find answers, hold negligent companies responsible and get you the compensation you deserve.

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For more information, see our: Guidant Recall Lawyers website

Guidant Defibrillator News Updates

Guidant Put Speed Ahead of Heart-Device Quality, Ex-Worker Says
Bloomberg - January 13, 2006
...Guidant Corp. reduced training and emphasized production speed over quality at its troubled factory making implantable heart devices in St. Paul, Minnesota, according to a 14-year worker who trained others there. Management set ``unrealistic'' goals for production of pacemakers and defibrillators and offered incentives for meeting them...

New York Attorney General Sues Defibrillator Maker; Spitzer alleges defect in Guidant's life-saving defibrillators
USA Today - November 3, 2005
Guidant (GDT) shares fell Thursday after New York Attorney General Eliot Spitzer accused the company of failing to inform physicians about a potentially fatal mechanical flaw in some of its surgically implanted heart defibrillators.  "We wouldn't permit this type of conduct in connection with the sale of cars or washing machines," Spitzer said. "It is simply unconscionable that it occurred with a critical medical device."

Implant Recalls Heighten Anxiety
Pittsburgh Post-Gazette - August 21, 2005
... Guidant knew of risks ... But the scrutiny of Guidant and other defibrillator makers may be just getting under way. In May, the New York Times said the Indianapolis corporation sold a defibrillator model it knew had a small risk of malfunctioning, but didn't issue warnings about it for three years.

Patients with defibrillators face tough choice
USA Today - August 11, 2005
... Patients recently learned that their pager-sized ICDs had a rare flaw that could cause them to short-circuit and fail just when they might need them to save their lives.

Heart implants raise questions as their use soars
International Herald Tribune; New York Times - August 3, 2005
... A little-known heart device, an implantable defibrillator, has been under the spotlight since a recent disclosure that a manufacturer, Guidant, did not tell doctors for years that one of its models had a defect that could render it useless.

Guidant And FDA Could Face Senate Scrutiny
WCCO.COM - July 31, 2005
... Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, asked the FDA to provide documents relating to Guidant's series of recalls.

F DA Announces Guidant’s Class I Pacemaker Recall
U.S. Food & Drug Administration Website - July 22, 2005
... The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients that Guidant Corporation is voluntarily recalling certain pacemakers. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

• PULSAR MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERY Models 1174, 1175, 1273, 1274, 1275
• MERIDIAN Models 0476, 0976, 1176, 1276
• PULSAR MAX II Models 1180, 1181, 1280
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• CONTAK TR Model 1241
• VIRTUS PLUS II* Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

* VIRTUS PLUS II and INTELIS II models available only outside the U.S.

Guidant adds to heart-device alerts; 28,000 patients effected
USA Today - July 19, 2005
....The nine types of pacemakers, which correct irregular heartbeats, may fail suddenly or cause a high rate for too long, Guidant says. It said a sealing component can degrade, allowing body fluids into the device.