FDA flags Edwards heart-valve delivery system issue after death, injury
15/10/2026 23:36
FDA flags Edwards heart-valve delivery system issue after death, injury Oct 15 (Reuters) - The US FDA on Thursday warned of a potentially high-risk issue involving certain Edwards Lifesciences EW.N 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 use and return impacted products.
(Reporting by Sahil Pandey in Bengaluru; Editing by Anil D'Silva)
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