Heart disease

FDA warns of bursting heart valve balloons

An image of a Sapien 3 heart valve attached to a thin balloon delivery system.
The Sapien 3 Ultra Delivery System. Photo: Edwards Lifesciences

Edwards Lifesciences is recalling almost 1,600 heart valve replacement systems after discovering balloons that are part of the device are rupturing inside the heart. The recall affects patients who have had surgery with the product since January.

Why it matters: One person has died and 17 others have been injured from the malfunctioning devices, according to the Food and Drug Administration. These types of heart valve products make up a majority of Edwards' $4 billion in sales.

FDA releases new proposed warning labels for cigarettes

Someone smoking a cigarette
Photo: David Butow/Corbis via Getty Images

The FDA is trying again to add graphic warnings to cigarette packages to discourage smoking, including images of neck tumors, diseased lungs and feet with amputated toes, AP reports.

Why it matters: The labels would also be included in tobacco advertisements. While small text warnings are currently included on cigarette packages, they haven't been updated since 1984 and “go unnoticed," the FDA said.