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Jump to Key Points Oct 15 (Reuters) - 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.
- FDA warns of potentially high-risk Commander M delivery system issue.
- Affected use: Edwards SAPIEN M3 TMVR system.
- Three balloon-burst reports; 1 death + 1 serious injury reported.
- Edwards requested removal/return of affected products from use.
- Balloon rupture may obstruct vessels or prevent retrieval; surgery may be required.
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)
