The New York Times, "FDA Expanding Inquiry Into Heart-Device Company"

          The Food and Drug Administration said yesterday that it would conduct an extensive inspection of the manufacturing facilities of the Guidant Corporation, a maker of implantable heart devices that is under scrutiny for the way it disclosed product problems.
          The agency's decision to conduct a comprehensive inspection could mean that its investigation into Guidant could extend for some time, rather than weeks, as one agency official initially suggested. It was not immediately clear whether the inspection had recently begun or would begin shortly.
          The review could also affect the timing of Johnson & Johnson's planned $25.4 billion acquisition of Guidant.
          The agency began a preliminary review of Guidant in late May after The New York Times reported that the company had not alerted doctors for three years that an electrical flaw in one of its defibrillators - the Ventak Prizm 2 Model 1861 - could cause some of them to fail when needed by heart patients. The company also continued to sell potentially flawed models after it had fixed the problem in newer versions.
          Since that disclosure, Guidant has issued recalls of other defibrillators and pacemakers that cover tens of thousands of the devices. A defibrillator sends out a strong electrical charge to disrupt a chaotic and often fatal heart rhythm. A pacemaker helps regulate a heart that is beating too rapidly or too slowly. Both devices are surgically implanted under the skin of the chest.