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Heart Device Recall
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Guidant ICD Recall
Defibrillator Lawyers Alert: FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators

There are approximately 50,000 patients in the United States with one of these recalled defibrillators. Guidant Corp. has said that the devices have malfunctioned at least 45 times, causing two deaths. Recalls linked to ICD's are not uncommon, and with heart disease still the number one cause of death in the United States, the safety of these medical devices is of great concern.

These surgically implanted defibrillators can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. The devices are implanted under the collarbone and wired to the heart of patients suffering from life-threatening heart arrhythmia (abnormal rhythm). When functioning properly the units can detect when the heart is beating out of rhythm, and deliver a series of electrical shocks to correct the arrhythmia.

The recalls are linked to a potential flaw where some could short circuit and not work at all. So, at the very moment when the patient's life depends on the reliability of the ICD, the device can malfunction.

A defibrillator is a medical device that uses an electric shock to the heart in order to
re-establish normal heart rhythm.

How Defibrillators Work


The MEDLAW Legal Team is a nationally recognized law firm dedicated to representing victims of faulty medical devices. Please learn more about our lawyers, and contact us for a free claim review.
   
The FDA has notified doctors and patients that the Guidant Corporation is recalling certain of its implantable defibrillators.

FDA Recall Statement

FDA Defibrillator Overview




What is a defibrillator?
Why has Guidant recalled several of their heart defibrillators?
When is it used?
How does it work?
What will it accomplish?
What are the risks?
What models of Guidant defibrillators have been recalled?
What about Electromagnetic Interference?
When should it not be used?
How do I know if my defibrillator is malfunctioning?
Why should I contact a lawyer?


What models of Guidant Defibrillators have been recalled?

The following implantable heart defibrillators have been recalled by Guidant Corp.:
  • 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

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.

How do I know if my defibrillator is malfunctioning?
There may not be any signs, but the FDA recommends:

  • 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.

Why should I contact a lawyer?
With the recall of certain Guidant defibrillators, there is some evidence that Guidant Corp. may have known of the faulty devices for some time prior to alerting the FDA, doctors, and patients. Negligently designed and manufactured medical devices place patients at risk and can have serious, life-threatening, effects. If you have one of these recalled heart defibrillators, and have suffered due to their malfunction, you may have a legal claim against the manufacturer.

Our in-house legal team consists of a physician, five registered nurses, 10 attorneys, and more than 30 staff-members. As one of the nation's premier pharmaceutical liability law firms, we represent consumers nationwide who have been victimized by defective pharmaceutical drugs and medical devices, including Guidant defibrillators.  We have the experience to protect your legal rights and to help you obtain the compensation you deserve.  If you or a loved one has suffered serious side effects from a defective defibrillator, please contact us for an immediate case evaluation.

Many law firms that advertise aggressively on the Internet are actually client brokers who refer virtually all clients to lawyers in other firms and other cities who do the actual work of representing the client. Janet, Jenner & Suggs, LLC, is a traditional law firm that actively represents all of our clients. Robert K. Jenner and Kenneth Suggs, leaders of the pharmaceutical department within the firm, will always be accessible to you. Mr. Jenner and Mr. Suggs, nationally recognized advocates on behalf of victims of defective pharmaceutical products, and their highly experienced team, will always be ready to answer your questions.


We encourage you to contact our lawyers today for an immediate free claim evaluation. You may be eligible to participate in a class action lawsuit on behalf of patients who have been injured, or who have died, due to the serious malfunction of Guidant ICDs. Call 1-888-4-MEDLAW or complete our online claim evaluation form.


 

 
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