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GUIDANT PACEMAKER* RECALL (implantable cardioverter-defibrillators): FDA Safety Advice Re: CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF
The following text was taken directly from the FDA website at: http://www.fda.gov/oc/po/firmrecalls/guidant062405.html
Guidant Corporation (NYSE: GDT) said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below. Guidant will continue its evaluation and communicate further as more information is learned. As a precautionary measure, physicians should discontinue implants of these devices pending further notice. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.
The devices impacted are:
CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF
Guidant has determined that the devices listed above are subject to a component failure that may limit available therapy. We have determined that a magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device's ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. In the four occurrences in which the device was implanted, patients and/or physicians were alerted to the condition by audible device tones that signaled the magnetic switch was closed. These four occurrences have resulted in device replacement. One occurrence occurred prior to implant. To date, there have been no patient injuries beyond device replacement.
It is Guidant's recommendation to physicians that they consider programming "Enable Magnet Use" to "OFF" to ensure that appropriate therapy to treat ventricular and atrial tachyarrhythmias will be provided in the event that the magnetic switch becomes stuck in the closed position. In addition, patients should contact their physicians or go to the hospital emergency room immediately if they hear tones from their device.
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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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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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