Guidant Pacemaker Recall
Guidant Defibrillator Recall
On June 17th 2005 Guidant Corporation recalled certain defibrillator models due to manufacturing defects. The United States Food and Drug Administration has determined that this June 17th advisory, related to both the Guidant defibrillator (ICD) and Guidant cardiac resynchronization therapy (CRT) devices, was classified as a Guidant Defibrillator Recall, also known as Guidant Pacemaker Recall. Even though pacemakers and defibrillators are different types of devices, both control the pace making function of the heart and sometimes the term "Guidant pacemaker" is used interchangeably by consumers. There was another safety advisory communication on Jun 24th related to the safety of cardiac resynchronization therapy devices. The June 24th communication was not considered a Guidant recall.
Guidant Products
Guidant is a large manufacturer and distributor of implantable cardioverter defibrillators (ICD), cardiac pacemakers and devices for cardiac resynchronization therapy (CRT). These ICD, pacemaker and CRT devices are used to treat abnormalities in heart rate and heart rhythm in patients who have heart disease or heart failure. The devices are implanted in the chest area and monitor heart function. If an irregularity is detected, then an electrical impulse (shock) or a series of impulses is/are delivered to the heart to restart normal function. Normally, defibrillators and pacemakers are implanted in older patients who have developed heart disease during the later stages of life. Due to improvements in pacemaker technology, these devices are now being widely implanted and used in younger patients who have congenital (at birth) heart problems. As such, these devices are being used for longer periods of time and the requirements for non-defective performance are more important.
Guidant Related Deaths
Heart disease remains one of the greatest causes of death in the United States. Heart failure, also known as cardiac arrest, occurs when the heart stops pumping properly. This illness leads to 200,000 to 400,000 deaths per year. The Guidant devices are designed to extend the lives of heart disease patients. However, if a defibrillator or pacemaker is defective, it could have devastating effects, including patient death. When the Guidant devices are defective, either the irregularity of the heart rate is not detected or the proper electrical impulses for treatment are not delivered to the heart. If the proper therapy is not provided, the heart can cease functioning properly and the patient could perish or suffer serious injuries due to lack of regular blood flow.
It is Guidant's responsibility to maintain the highest quality standards for these products and insure that if any quality issue arises, immediate steps are taken to protect the patients. Physicians who use Guidant products must maintain records of which models are implanted in which patients so as to properly advise patients when a manufacturing defect is discovered. Guidant is responsible for making any potentially dangerous defect known to the doctors and patients immediately, whenever such information becomes known to them. Multiple deaths related to the Guidant defibrillator recall and Guidant pacemaker recall defect have been reported.
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