FDA warns of bursting heart valve balloons
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.