FAQ"s and Facts About Guidant Pacemaker Recalls

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Since 2005 the pacemaker manufacturer Guidant has announced three major recalls of its surgically implanted pacemakers.
Patients with affected devices may experience inappropriate sensing or premature battery depletion.
Patients whose device was recalled in any of the three recalls have been urged to consult their physicians as soon as possible.
The FDA has urged physicians to conduct a thorough examination of affected patients as soon as possible, to assess the functioning of the suspect device.
What kind of risk do users of recalled Guidant pacemakers face? Patients rely on their implanted pacemaker to maintain a steady heart rate.
If their pacemaker fails, they face the possibility of stroke, heart attack, or death.
All of the Guidant heart defibrillators-pacemakers on the recall lists put patients at seriously increased risk of heart attack, stroke and even death.
Replacement or removal of the device is a surgical procedure requiring full anesthesia, presenting additional risk to patients.
Patients with affected pacemakers could experience or premature battery depletion or intermittent or permanent, irreversible device failure.
If I have a Guidant pacemaker or defibrillator, what should I do? As soon as possible you should contact your physician to determine whether the device you're relying on is one of the models recalled by Guidant.
You should follow your physician's recommendations.
How many Guidant pacemakers and defibrillators have been recalled? To date, Boston Scientific, which owns Guidant, has recalled 136,950 pacemakers and defibrillators.
If I have a defective Guidant device, do I have a legal claim? If you or a loved one has been injured by a Guidant pacemaker or defibrillator, you should consult an experienced medical device lawyer to evaluate your case.
Claims and lawsuits involving Guidant devices usually have elements of manufacturer liability, individual health, and the quality of your medical care.
An experienced medical device lawyer can sort through these elements, and help you determine your best course of action.
Who is affected by the Guidant defibrillator-pacemaker recall? Anyone whose pacemaker is on the Guidant recall list below is at risk.
A pacemaker's primary function is to restore heart rhythm in patients who suffer from life-threatening heart arrhythmia a defective pacemaker which malfunctions or fails can be extremely dangerous, exposing the patient to risk of heart attack, stroke, and even death.
The following Guidant defibrillator-pacemaker models have been recalled: Models recalled June 2005
  • Renewal 4 AVT (all models)
  • Renewal 3 AVT (all models)
  • Vitality AVT (all models)
  • Ventak Prizm AVT (all models)
  • Contak Renewal 2 (model #H155-Manufactured on, or before, August 26th, 2004)
  • Contak Renewal (model #H135)
  • Ventek Prizm 2 DR (model #1861-Manufactured on, or before, April 16th, 2002)
Models included in the June 2006 recall
  • Insignia brand pacemakers
  • Nexus brand pacemakers
  • Contak Renewal TR/TR2 cardiac resynchronization pacemakers
  • Ventak Prizm 2 cardioverter defibrillators
  • Vitality cardioverter defibrillators
  • Vitality 2 cardioverter defibrillators
Should you consult an attorney? If you or a loved one used or continue to use one of the recalled Guidant pacemakers, you should contact an attorney immediately for review of a potential claim against the manufacturer.
There are deadlines set by laws which regulate the filing of lawsuits called statutes of limitation, which vary state by state.
If you know that you or a loved one was harmed by a Guidant, you should not delay in contacting an attorney.
If the statute of limitations expires, your right to pursue a claim against the manufacturer may be forever barred.
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