Three new deaths associated with Guidant devices: NYT

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.