FDA issues warning about heart pump linked to deaths
A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration's decision to issue a warning about the risk that it could perforate a wall of the heart.Tiny Impella pumps, about the size of a candy cane, are threaded into blood vessels to take control of the heart's work in patients undergoing complex procedures or life-threatening conditions.The FDA said the device's manufacturer, Abiomed, should have alerted the agency more than two years ago, when the company first posted an update on its website about the perforation risk. Such a notice, the FDA added, would have led to a much broader official warning to hospitals and doctors.The warning is the latest in concerns raised...