FDA Letter Recommends Removing Some Sapien M3 Delivery Systems
The FDA is aware Edwards Lifesciences issued a letter recommending removal of some delivery systems used for Sapien M3 transcatheter mitral valve replacement.
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10:36:15 PM UTC
SquawkNews
The US FDA on Thursday warned of a potentially high-risk issue involving certain Edwards Lifesciences NYSE:EW delivery systems used in transcatheter mitral valve replacement after one death and one serious injury.The FDA said Edwards Lifesciences had asked customers to remove affected devices from…