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GUIDANT PACEMAKER RECALL. GUIDANT ICD RECALL.
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GUIDANT PACEMAKER* RECALL (implantable cardioverter-defibrillators): FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators
The following text was taken directly from the FDA website at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01185.html
FDA is notifying 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
The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.
"FDA's first priority is patient safety," said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health. "We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians."
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.
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.
Guidant also recently informed 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. Currently, FDA is evaluating this information.
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If you have been implanted with any of these devices, you are urged to contact our law firm immediately to protect your legal rights.
Our law firm is currently investigating potential personal injury and/or class action cases against Guidant, and if you think that you may have been harmed by your Guidant ICD (pacemaker), you are strongly encouraged to contact us. There is no charge, and no obligation. If we take your case, there is no fee for our services unless we win your case, or settle it in your favor.
On the other hand, if you fail to protect your legal rights now, you may lose the right to be compensated for your harm. (Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred).
Our firm has a great deal of experience in representing plaintiffs in “defective medical device ” cases, and in fact, is currently pursuing cases against Guidant for their "Ancure" stent device.
In addition, we have the resources to handle our own cases. This means that when you call our firm, you talk to your own lawyer who has been assigned to your own case.
Please contact us now (your privacy is assured). The secure form below only takes a couple of minutes to fill out, but if you are uncomfortable sending your information over the internet, please call our toll-free number at 800.921.1776 to speak to an attorney. The call is free, and there is no obligation. Act now, as delays can harm your case.
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Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.
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Alexander Hawes, LLP, an AV-rated trial firm, has concentrated its practice on the prosecution of complex Personal Injury and Class Action cases. The Firm represents individuals, governmental entities, businesses and institutional shareholders in auto accident cases, insurance claims, motorcycle injury accidents, and truck (and SUV) accidents. In addition, our law firm represents consumers in defective product, product liability, tort, negligence, mass tort, consumer, construction defect, investment fraud, price fixing and employment cases. The Firm is currently involved in complex cases pending in federal and state courts throughout the Unites States. The Firm is dedicated to quality representation of its clients and prides itself on aggressive advocacy of its clients' claims.
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