Aug 22, 2019

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.

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Minneapolis unrest as hundreds protest death of George Floyd

Protesters and police clash during demonstration on Wednesday over the death of George Floyd in custody outside the Third Police Precinct. Photo: Kerem Yucel/AFP via Getty Images

Minneapolis police clashed for a second night with protesters demonstrating the death of George Floyd, an African American man who died in police custody.

The latest: Minnesota Gov. Tim Walz tweeted late Wednesday that the situation where the clashes were taking place was "extremely dangerous" as he urged people to leave the area. There were multiple news reports of police firing tear gas at protesters and of some people looting a Target store.

Blue Cross Blue Shield insurers sue CVS, alleging drug pricing fraud

Photo: John Lamparski/SOPA Images/LightRocket via Getty Images

Six Blue Cross Blue Shield insurers have sued CVS Health, alleging the pharmacy chain overcharged them based on "artificially inflated prices" for generic drugs and concealed the true cash prices of those drugs.

The big picture: CVS has faced legal scrutiny over its cash discount programs since 2015, and this lawsuit adds big names to a mounting problem.

World coronavirus updates

Data: The Center for Systems Science and Engineering at Johns Hopkins; Map: Axios Visuals

New Zealand has only eight active novel coronavirus cases and no COVID-19 patients in hospital after another day of zero new infections. However, the death toll rose to 22.

Zoom in: A top health official told a briefing a 96-year-old woman "was regarded to having recovered from COVID-19 at the time of her death, and COVID-19 is not recorded as the primary cause of her death on her death certificate." But it was decided to include her in the overall tally of deaths related to the virus.