Product recalls

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.

Allergan breast implants linked to rare cancer face global recall

The Food and Drug Administration requested that Allergan, a company that manufactures textured breast implants, voluntarily recall the devices on Wednesday, based on their link to an unusual form of cancer.

Why it matters: 573 cases and 33 deaths from anaplastic large cell lymphoma have been reported around the world, according to FDA data. Of the 573 cases, 481 have been attributed to the Allergan product.