FDA flags Edwards heart-valve delivery system issue after death, injury
EW•The FDA warned of a potentially high-risk issue with certain Edwards Lifesciences delivery systems after reports of three balloon bursts, one death and one serious injury. The company asked customers to stop using and return affected devices.
1. FDA warning
The FDA warned of a potentially high-risk issue involving certain Edwards Commander M delivery systems used with the SAPIEN M3 transcatheter mitral valve replacement system. Edwards Lifesciences asked customers to remove affected products from use and return them after receiving three reports of balloons bursting during inflation; as of October 5, the company reported one associated death and one serious injury.
2. Potential complications
The FDA said balloon bursts could block blood vessels or prevent retrieval of the device, potentially requiring additional procedures, including surgery. The devices are used in patients generally considered unsuitable for surgery. The SAPIEN M3 system received U.S. approval in December 2025.
