Guidant Renewal 2 defibrillator
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CONTAK RENEWAL 2 (Model H155) suffers from a potentially fatal mechanical flaw that has been responsible for 15 failures and two deaths. The insulation on a wire in the lead connector block can deteriorate which may cause a short in the active titanium block resulting in a critical malfunction. This short prevents the device from delivering the proper shock to prevent a cardiac arrhythmia.
There have been 28 reports of failure of CONTAK RENEWAL 2 devices worldwide, which have unfortunately caused at least one death. Guidant Corp speculates that there are approximately 11,900 defibrillators with this potentially lethal design flaw, 6700 in the United States alone. Guidant was aware of this design flaw, but marketed the device as safe, rationalizing the defect would be corrected in future models.
What
is a defibrillator?
