Attorney News: Guidant Recalls Defibrillators

BREAKING NEWS: 10.15.07--Medtronic, Inc., the world's largest maker of electronic heart devices, announced they are suspending sales of Sprint Fidelis leads. According to the FDA, these wires, used to connect defibrillators to the heart, may break or erode and may increase chance of injury. Learn more about the Medtronic Sprint Fidelis Recall.

Weitz & Luxenberg provides this FREE Guidant recall information from a Guidant Corporation press release issued Friday, June 17, 2005. The Guidant Corporation recalled several Guidant defibrillator models that can have serious implications for you and your health. If you or a loved one has been injured by a faulty Guidant defibrillator, fill out this simple form and have a Weitz & Luxenberg attorney help.

Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action About Implantable Cardiac Defibrillators

Indianapolis, Ind., June 24, 2005 — 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 obtained. 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 occurrences. 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 a 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.

Guidant Corporation recommends 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. Furthermore, patients are advised to contact their physicians or go to the hospital emergency room immediately if they hear tones coming from their device.

Guidant continues to investigate this issue and will provide all additional information that may help physicians and patients.

Guidant recently announced its intention to establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices. Guidant plans to cooperate with and enlist the support of other interested parties, including the Food and Drug Administration, patient advocates, and physician societies.

Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/RENEWAL3_RENEWAL4.pdf.

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ACT NOW!!! It is essential that you inquire about your case as soon as possible. Litigation may be the only way to receive the damages to which you may be entitled, such as medical and health care bills, lost or diminished wages, and financial compensation to family in the case of death. Your individual state's law may limit your time to bring a legal claim to protect your rights. You need to have your Guidant Defibrillator claim evaluated immediately!

Weitz & Luxenberg is no longer accepting Guidant Defibrillator cases.

see also:

Guidant Release Guidant Recalls Dangerous Models
Certain Guidant Defibrillators Are Dangerous -May Cause Serious Injury

Weitz & Luxenberg Release Our Press Release About Guidant Defibrillator Recall
Recall of Guidant Defibrillators - Do You Have a Case?

Recall Guidant Defibrillator: Learn the dangers and how a lawsuit can help
Learn more about the Guidant Defibrillator lawsuit