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Illinois Guidant Medical Devices Litigation Law FirmChicago Defective Medical Devices Attorneys
Guidant Corporation manufactures defibrillators, pacemakers and the stents that have been recalled due to evidence indicating that the medical devices can cause serious medical complications or death. As a consumer protection law firm based in Chicago, Illinois, The Law Group, Ltd. is committed to protecting the public and consumers from unsafe products, including defective medical devices, unsafe pharmaceuticals, and dangerous consumer products. If our or a loved one has used a Guidant medical device, such as an implantable defibrillator or pacemaker, contact the knowledgeable defective medical device attorneys at The Law Group at (312) 558-6444 to learn more about how we can help you recover for your injuries.
Guidant Defibrillators Guidant produces implantable defibrillators, which were recalled by the FDA in 2005. The implantable defibrillators’ function is to maintain a normal heart rhythm by delivering an electric shock to the heart when necessary after surgical implantation. However, various models of Guidant Defibrillators have a defect that causes the device to develop an internal short circuit, which can lead to the failure of the device to deliver a shock to the heart when necessary. The result of this defect is extremely dangerous, and is the suspected cause of two deaths. At least 26 cases are known where the defibrillator has failed in this manner.
The defect in the devices causes an internal short circuit which can lead to the device failing to deliver a shock to the heart when necessary, and can lead to a serious, life threatening event for the patient. The FDA has classified Guidant's action as a Class I recall, which is the most serious.
Guidant Pacemaker Guidant’s pacemakers were recalled in 2005 after the company received 69 reports that various models of its pacemakers have failed and have been the cause of at least one death. The defect causing the failure is in the pacemaker's seal, which allows moisture to leak into the device and affect its electronic circuits. As a result, the device fails to provide pacing or causes a rapid heart rate. These problems can occur without warning, and possibly lead to heart failure and death.
Like the recall of Guidant’s implantable defibrillators, the FDA has classified the Guidant pacemaker recall as a Class I recall, which means that there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.
Some patients are very dependent on pacemakers to maintain an adequate heart rate. For these patients, failure of the device to provide pacing output can cause sudden faintness or loss of consciousness, and can result in death. The leakage defect can also cause a sustained rapid heart rate, which can cause heart failure and result in death.
While pacemaker failure can occur without warning, sometimes a physician can detect a leak related malfunction before any serious complications occur. Guidant has provided information to physicians about ways to identify a leak related malfunction. However, Guidant is not aware of any test that will show if a normally functioning pacemaker is likely to fail in the future. |
