Guidant Defibrillator
In June 2005, Guidant Corporation issued a recall for its implanted cardiac defibrillators (ICDs) because of flaws in the products' design that result in potentially life-threatening effects. The recalled models include the VENTAK PRIZM 2 DR (Model 1861), the CONTAK RENEWAL (Models H135 and H155) and the VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 4 AVT and RENEWAL 3 AVT ICDs. It is also feared that the ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by Medtronic, Inc may be afflicted with similar defects.
Defibrillators operate by shocking the patient's heart back into a normal rhythm when it begins to beat irregularly. ICDs are defibrillators that are surgically implanted into the patients upper chest and then connect by wire to the electrical control nodes of the heart. The PRIZM 2 and CONTAK models have an electrical defect that causes them to short-circuit and prevents the device from being able to properly shock the patient's heart when it begins to beat irregularly. The VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 4 AVT, and RENEWAL 3 AVT ICDs have a memory error that requires reprogramming in order to prevent a similar malfunction.
Guidant has already come under scrutiny because there is evidence to show that it was aware of these defects and failed to warn prescribing physicians of them until after it learned that the New York Times was preparing an article about these defects.
There have already been 45 confirmed malfunctions in these defibrillators. These malfunctions can and have already resulted in multiple deaths. ICDs that have not already malfunctioned may do so at any time.
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