Following Reports of 17 Deaths, Boston Scientific Updates Instructions for Watchman Heart Device Components
Boston Scientific has issued updated instructions for products used in the implantation of its Watchman left atrial appendage closure device after the Food and Drug Administration (FDA) linked the procedure to 120 serious injuries and 17 patient deaths.
FDA Safety Alert Highlights Increased Risk Under Sedation
According to an FDA safety communication released on August 8, 2025, the updated instructions apply to the FXD Curve, Truseal, and Trusteer access systems—all of which are used to implant the Watchman device. The FDA warned that patients sedated but not placed on mechanical ventilation during the procedure face a heightened risk of air embolism, a dangerous condition caused when an air bubble enters the bloodstream.