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Report: More deaths linked to Guidant
FDA reports show three additional deaths connected to company's heart devices, newspaper says.
December 14, 2005: 8:43 AM EST

NEW YORK ( - Guidant Corporation has notified the Food and Drug Administration of several new reports about recent patient deaths associated with short circuits in its heart devices, according to a published report.

The New York Times reported Wednesday the three deaths all occurred after June when Guidant recalled the heart devices at issue. The recalls took place after the company came under scrutiny for failing to promptly warn doctors and patients about the risks of short circuits, the newspaper reported.

Shares of Guidant (Research) lost $1.64, or 2.4 percent, to $65.66 in pre-market trading on Inet following the report.

Problems with the heart devices has battered the company's stock since the summer and almost caused Johnson & Johnson (Research) to call off its agreed-upon $23.9 billion purchase of Guidant earlier this fall.

Guidant's board eventually agreed to a lowered $21.5 billion sales price by J&J, worth $63.06 a share. But that lowered bid prompted another suitor, Boston Scientific (Research), to enter the bidding with a $25 billion offer, worth $72 a share, for the rival medical device maker.

Guidant is now in discussions with both companies about its future.

The Times said the new FDA reports bring the number of known deaths associated with the flaw in Guidant equipment to seven, and that the new data may pose further legal problems for Guidant. The electrical failures, while involving different models, are all related to the company's use of an insulating material in a way that apparently made it prone to deterioration, according to the newspaper.

Guidant, in a statement to the newspaper, said it "regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies." The company also told the newspaper that it recently began publicly releasing more detailed data about product malfunctions.

The FDA recalled more than 63,000 of Guidant's cardiac defibrillators across a number of the company's product lines in June, and another 28,000 devices were recalled the next month. The Times reports devices at issue include a defibrillator known as the Prizm 2 DR as well as a combination pacemaker and defibrillator known as the Contak Renewal and a related product, the Contak Renewal 2.


For a look at the bidding war over Guidant, click here.  Top of page

Guidant Corporation
Food and Drug Administration (FDA)
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