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product_liability guidantGuidant Pacemaker Recall
In response to the June 17th, 2005 safety advisory issued by the Guidant Corporation about their pacemaker products, the FDA has ordered a Guidant pacemaker recall. Guidant is a large manufacturer of implantable cardiovascular devices designed to regulate heart abnormalities in persons with heart disease and failure. The Guidant pacemaker is a device that is implanted into the chest area to regulate and monitor the patient''s heart rate. If an irregularity is detected, the Guidant pacemaker sends an electronic impulse to the heart to restore normal functioning.
The FDA Guidant pacemaker recall requires the corporation to contact doctors and patients to notify them of the risks associated with the devices. The Guidant pacemaker recall affects approximately 50,000 of the devices that have been deemed defective. These devices, designed to prolong the lives of those suffering from heart disease, have demonstrated risk of being inadequate at detecting heart irregularities as well as sending improper electronic impulses to the heart. The consequences of this defect in the Guidant pacemaker could potentially result in serious injury or even death due to lack of proper blood flow.
On December 22, 2005, the FDA issued a letter of warning to Guidant in regards to the Guidant pacemaker recall, limiting the ability of the company to gain approval for new devices. These restrictions, which could severely thwart the progress of the company, also prevent the company from exporting devices made in the facility in Saint Paul, Minnesota. The warning highlighted eight specific deficiencies with the devices and ordered Guidant to fix them promptly or more severe penalties may be pursued. Guidant has been given 15 days to reply to the warning and has responded by issuing a statement saying that they will fully address the FDA''s concerns.
The Guidant pacemaker recall has not yet been categorized by the FDA but is predicted to fall under Class II. Both the Ventak Prizm 2 DR Guidant heart defibrillator created before April 16, 2002 and the Contak Renewal Guidant heart defibrillators built before August 26, 2004, contain serious wiring problems that have resulted in two deaths. The Ventak Prizm AVT, Vitality AVT and Renewal AVT Guidant heart pacemaker devices all contain memory errors that could potentially affect the ability of the electrical impulses to function properly.
There have been two deaths and 45 reported cases of device malfunctioning since the Guidant pacemaker recall. Plans for an acquisition of Guidant Corporation by Johnson and Johnson have now resulted in a $4 billion drop in the selling price from $25 to $21.5 billion. Johnson and Johnson is currently in competition with Boston Scientific who has offered to pay $25 billion for the company.
Request more detailed Guidant pacemaker recall information and submit your potential case for a free and confidential consultation by contacting the experienced product liability lawyers of Miller and Associates
Product Liability Breaking News
"Guidant Heart Defibrillator Claims"
Boston Scientific Corp. has amended a settlement agreement involving faulty Guidant defibrillator claims to include an additional $45 million, bringing the total settlement amount to $2...
"FDA Urges Patients to Schedule Exam"
A statement released yesterday by the U.S. Food and Drug Administration urged patients with potentially defective models of Boston Scientific/Guidant pacemakers and defibrillators to schedule an exam with their physicians as soon as possible.
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"Defibrillators May fail 10 times more than projected"
A U.S. Food and Drug Administration analysis found that Guidant defibrillators may fail as much as 10 times more than the company projected last year.
Guidant defibrillators have been implanted into thousands of cardiac patients and are used t...
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