Guidant Corporation has filed three death reports with FDA since recall of defibrillators

01/10/07

The New York Times reported today that Guidant Corporation, maker of the heart defibrillators that have been the subject of a wave of recent recalls due to short circuits and other defects, has filed reports with the U.S. Food and Drug Administration about three more deaths associated with defects in their devices since they were recalled. Including the most recent reports, the total number of deaths associated with flaws in Guidant heart devices has now reached seven.

The New York Times said doctors and families of heart patients might be more likely to have the units checked for problems because of the increased scrutiny on Guidant. Guidant received a U.S. Justice Department subpoena in October 2005 concerning some of the recalled devices and is currently a takeover target among competitors in the medical device market. Both Johnson & Johnson and Boston Scientific Corporation have made offers for the troubled company.

Source: Barry Meier, “More Deaths are Linked to Device,” New York Times, December 14, 2005; “Report: More deaths linked to heart devices,” Reuters, December 14, 2005.

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