More Deaths Reported to FDA after Guidant Recall

posted on:
December 15, 2005


Recent reports have surfaced about new patient deaths associated with fatal complications from heart devices manufactured by Guidant Corporation.

Each of these new cases occurred after June, when the company was forced to recall the devices after evidence of deadly short circuits emerged. Agency records show that the Food and Drug Administration has recently received these new reports, which brings the number of known deaths associated with the flaw to seven.

This new development is yet another example of the widespread problems that have plagued the Indianapolis-based medical device maker since 2002, when Guidant discovered that one of its heart devices was prone to short-circuiting.

Since then, the troubled company has recalled about 200,000 pacemakers because of reported malfunctions and has recalled or issued warnings about 88,000 heart defibrillators. In October, the U.S. Justice Department subpoenaed Guidant over the recalled devices as part of an investigation into the companys handling of safety issues.

Dangerous and potentially deadly complications have been linked to both the companies defibrillators – devices that sense and interrupt irregular heart rhythms – and pacemakers, which electrically stimulate the heart to regulate heartbeat. In a statement, Guidant said there were now five patient deaths associated with short circuits in either a Contak Renewal or a Contak Renewal 2, and two such deaths associated with the Prizm 2 DR.

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