Burst Balloons Prompt Edwards to Recall Sapien 3 Ultra Delivery System

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, Aug 22, 2019 at 5:22 PM.

  1. #1 cafead, Aug 22, 2019 at 5:22 PM
    cafead

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    via Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to recall 1,585 Sapien 3 Ultra delivery systems from the U.S. market. The company initiated the recall in July but FDA just issued the associated safety alert on Thursday.

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