Guidant Corp, a cardiovascular device maker, commissioned an outside panel to review its products after public recalls and numerous lawsuits including a U.S. Department of Justice inquiry (DoJ) and a U.S. Food and Drug Administration (FDA) criminal investigation.
Guidant, which is being acquired by Boston Scientific Corp, says that the 12-person panel recommends it "develop processes to identify and act on even a single device malfunction when it is associated with the risk of death or serious injury."
Robert Myerburg, professor of medicine at the University of Miami, who led the panel, says, "We found overall device reliability to be well within acceptable performance... but internal and external communications methods burdened the company's ability to manage and communicate low-frequency malfunctions."
