The litigation continues as Guidant Corporation has issued yet another recall of their popular defibrillator and pacemaker devices. This most recent recall affects over 27,000 devices and is in connection to an internal mechanism defect – low-voltage capacitor problem. The June recall affects the following devices:
INSIGNIA and NEXUS pacemakers,
CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers,
VENTAK PRIZM 2,
VITALITY; and
VITALITY 2 implantable cardioverter defibrillators.
The defibrillators and pacemakers, which were recalled by Guidant and Medtronic two years ago due to premature battery death, attributed to improperly insulating wires. Guidant Corporation has warned doctors that about 28,000 of its earlier generation pacemakers may malfunction and need to be replaced in some patients. The problem involves a bad seal, which allows moisture into the pacemaker causing it to gradually degrade. For patients that depend on the pacemakers to maintain a normal heart rate, failure of the device can cause sudden faintness or loss of consciousness, and can result in death.
Since the summer of 2005 there have been over 236,000 defective defibrillators and pacemakers recalled from the US market due to a variety of problems such as device failure relating to battery depletion and other problems associated with adverse cardiovascular events and unfortunately many deaths among patients.
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