More Recalls of Guidant Defibrillators
On June 26, 2006, Boston Scientific, which acquired Guidant in April, 2006, announced the recall of a new subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. The new subset includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, and VITALITY 2 implantable cardioverter defibrillators. According to Guidant's June 23, 2006, Dear Doctor Letter titled, "Urgent Medical Device Safety Information and Corrective Action." a problem with a supplier's low voltage capacitor was "not performing to the company's expectations." Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion.
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