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Three new deaths associated with Guidant devices: NYT

Posted on: Wednesday, 14 December 2005, 03:21 CST

NEW YORK (Reuters) - Guidant Corp has filed reports with the U.S. Food and Drug Administration about three new deaths associated with short circuits in its heart devices, the New York Times reported on Wednesday.

Citing agency records, the newspaper said the deaths occurred after Guidant recalled the heart devices at issue in June.

Medical-device maker Guidant has faced intense scrutiny in recent months over its failure to inform doctors about potential defects in some of its implantable devices used to manage abnormal heartbeats.

It eventually recalled some of its most lucrative implantable heart devices because of concerns about their safety. Sales have since resumed.

Including the new reports, total deaths associated with the flaws have reached seven, the Times said. It said doctors and families of heart patients may be more likely to have the units checked for problems after a death because of the increased scrutiny on Guidant.

According to the report, Guidant said it "regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies," and has recently been releasing more detailed information about product malfunctions.

In October, Guidant said it had received a Justice Department subpoena concerning some of those recalled heart devices, which regulate abnormal heart rhythms and guard against heart failure. Two other makers of heart devices also got subpoenas.

Guidant, which is the target of competing takeover offers from Johnson & Johnson and Boston Scientific Corp., was not immediately available for comment.

Source: REUTERS

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