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Oct 15 — The US FDA on Thursday warned of a potentially high-risk issue involving certain Edwards Lifesciences 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 products from use and return them after receiving three reports of balloons bursting during inflation.
The company reported one death and one serious injury associated with the issue as of October 5.
The affected devices are certain Commander M delivery systems used with Edwards' SAPIEN M3 transcatheter mitral valve replacement system, which received US approval in December 2025.
The FDA said balloon bursts could block blood vessels or prevent retrieval of the device, potentially requiring additional procedures, including surgery, in patients generally considered unsuitable for surgery.
(Reporting by Sahil Pandey in Bengaluru; Editing by Anil D'Silva)
