Guidant Defibrillators, also called Implantable Cardioverter Defibrillators or ICDs, are implanted into patients with congestive heart failure, abnormally fast heart rhythms / tachycardia or irregular heartbeats. The defibrillator is designed to shock a faltering heart. According to the American Heart Association, 64,000 implantable defibrillator operations are performed on U.S. patients each year.
In June 2005, Guidant Corporation recalled thousands of their Implantable Cardioverter Defibrillator (ICD) due to a manufacturing defect that may cause the device to short-circuit or malfunction. It is alleged that Guidant knew of the problems with their heart defibrillators and failed to publicly disclose the life-threatening defects until FDA intervention and public scrutiny
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There are approximately 50,000 patients in the United States implanted with these recalled defibrillators. Guidant Corp. has said that the devices have already malfunctioned at least 45 times, causing at least two deaths. Recalls linked to ICDs are not uncommon, and with heart disease still the number one cause of death in the United States, the safety of these medical devices is of great concern.
The devices are implanted under the collarbone and wired to the heart of patients suffering from life-threatening abnormal heart rhythm. When functioning properly, the units are supposed to be able to detect when the heart is beating. Although the recall has periodically expanded to include additional models, the recall list presently includes the following models:
- VENTAK PRIZM 2 DR (Model 1861)
- VENTAK PRIZM AVT
- CONTAK RENEWAL (Model H135)
- CONTAK RENEWAL 2 (Model H155)
- VITALITY AVT
- RENEWAL 3 AVT
- RENEWAL 4 AVT
If you have one of the recalled Guidant defibrillators, contact your doctor immediately to discuss your medical options. For any given patient there are numerous alternatives, and the patient’s cardiologist can recommend an appropriate course of action individualized for the patient's health concerns. 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.
Currently, Guidant faces several hundred individual lawsuits and class action lawsuits related to its defibrillator and pacemaker products. Guidant may also face a civil lawsuit by the federal government for failing to disclose its product's potentially fatal defects. Medical professionals and legal professionals believe that Guidant withheld pertinent information about defibrillator malfunctions and mechanical design defects. It is alleged that Guidant learned of their ICDs life-threatening defects in 2002, but did not disclose this information to the public until 2005 while heavily marketing their products worldwide.
Our firm maintains offices in Austin, Houston and San Antonio, Texas, and we represent clients throughout the state of Texas and the United States. Contact us today at (800) 892-5044 or through our online form.
For more information, please see our Medical Devices Frequently Asked Questions.
