Pacemakers

What is the Boston Scientific Guidant heart defibrillator-pacemaker recall?

Between 2005 and 2007, Guidant, a major manufacturer of medical devices, announced three massive recalls of potentially defective cardiac defibrillators. In all, Guidant has recalled more than 200,000 surgically implanted devices. Boston Scientific purchased Guidant Corporation in April 2006, thereby assuming responsibility for any liability regarding Guidant heart defibrillators and pacemakers.

Some Guidant Heart Defibrillators-pacemakers may have defective wiring that could keep them from functioning properly after installed. Other devices may have memory problems that can adversely affect their performance. The most recent devices recalled could malfunction due to the failure of a low-voltage capacitor. Patients with affected pacemakers could experience intermittent or permanent, irreversible device failure or premature battery failure.

The US Food and Drug Administration (FDA) has advised all patients who had any of the surgically implanted Guidant heart defibrillator or pacemaker models involved in the recall to contact their physician immediately. The FDA urged physicians to conduct a thorough examination of affected patients as soon as possible, to assess the functioning of the suspect devices.

What health problems are associated with the Boston Scientific Guidant heart defibrillator-pacemaker?
Patients with any of the Guidant heart defibrillators-pacemakers on the recall lists may experience inappropriate sensing, premature battery depletion or battery failure. All of the affected devices put patients at increased risk of heart attack, stroke and even death.

Replacement or removal of the device is a surgical procedure requiring full anesthesia, presenting additional risk to patients. If you or a loved one is relying on any of the defective Guidant defibrillator-pacemaker models listed below, Casey Gerry defective medical device attorneys recommend you contact your physician as soon as possible.

Who is affected by the Guidant defibrillator-pacemaker recall?
Anyone whose pacemaker is on the recall list below is at increased risk. A pacemaker’s primary function is to restore heart rhythm in patients who suffer from life-threatening heart arrhythmia a defective pacemaker which malfunctions or fails can be extremely dangerous, exposing the patient to risk of heart attack, stroke and even death.

Since the time of the first recall in 2005, numerous cases of Guidant Defibrillator-pacemaker failure have been reported. Several deaths have been linked to the malfunctioning devices.

What should you do if you have had a Guidant heart defibrillator-pacemaker implanted?
If you have any symptoms that you feel may be related to your Guidant defibrillator or pacemaker, or if you have questions about its safety, you should immediately consult with your physician.

Boston Scientific is suggesting that Guidant Heart Defibrillator-Pacemaker patients consult with their healthcare provider to determine a course of action. Removal or replacement of a Guidant Heart Defibrillator or pacemaker involves costly surgeries that should not be the burden of the patient.

Which Guidant Defibrillator-Pacemaker Models have been recalled?
The following Guidant defibrillator-pacemaker models have been recalled:

Models included in the most recent recall, in April 2007

• Contak Renewal 3 HE CRT-Ds (Models H177 and H179)
• Contak Renewal 3 CRT-Ds (Models H170 and H175)
• Vitality 2 DR ICDs (T165)
• Vitality 2 VR ICDs (T175)
• Vitality AVT ICDs (A155)
• Vitality DS DR ICDs (T125)
• Vitality EL DR ICDs (T135)

Models included in the June 2006 recall

• Insignia brand pacemakers
• Nexus brand pacemakers
• Contak Renewal TR/TR2 cardiac resynchronization pacemakers
• Ventak Prizm 2 cardioverter defibrillators
• Vitality cardioverter defibrillators
• Vitality 2 cardioverter defibrillators

Models recalled June 2005

• Renewal 4 AVT (all models)
• Renewal 3 AVT (all models)
• Vitality AVT (all models)
• Ventak Prizm AVT (all models)
• Contak Renewal 2 (model #H155-Manufactured on, or before, August 26th, 2004)
• Contak Renewal (model #H135)
• Ventek Prizm 2 DR (model #1861-Manufactured on, or before, April 16th, 2002)

Should you contact a medical device attorney?
If you or a loved one has had a Guidant pacemaker or defibrillator implanted, and have experienced serious symptoms or complications, you should contact an experienced medical device attorney immediately for review of a potential claim. There are deadlines set by laws, called statutes of limitation, which regulate the filing of lawsuits. These statutes of limitation vary state by state. If you know that you or a loved one was harmed by a Guidant pacemaker or defibrillator, you should not delay in contacting a medical device lawyer. If the statute of limitations expires, your right to pursue a claim against the manufacturer may be forever barred.

How Casey Gerry medical device attorneys can help you with a Guidant Defibrillator-Pacemaker case
Casey Gerry, based in San Diego, is one of the oldest and most respected personal injury firms in California, and has a proven track record of success in pharmaceutical litigation. Firm partner Gayle Blatt and her associate Wendy Behan have worked in such high-profile national pharmaceutical and medical device cases as L-Tryptophan, Baycol, the Sulzer hip, Propulsid, Rezulin, and Metabolife. They work with individual clients, rather than class actions, so that they can focus on their clients’ specific needs.

Medical device attorneys Gayle Blatt and Wendy Behan are currently evaluating claims on behalf of individuals around the country who have been seriously harmed by a Guidant heart defibrillator-pacemaker.

If you believe that you or a loved one may have been injured as a result of using a Guidant heart defibrillator-pacemaker, please contact us immediately for evaluation by an experienced medical device attorney.