FDA Issues Early Alert on Boston Scientific’s Watchman Access System

August 11, 2025—The FDA recently advised that Boston Scientific has issued a letter to affected customers recommending all lots of certain Watchman access systems have updated instructions for use (IFU). The devices are intended to provide vascular and transseptal access for Boston Scientific’s family of Watchman FLX left atrial appendage closure devices with delivery systems.

The reason for the action is that Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.

The FDA alert advised that as of July 30, Boston Scientific has reported 120 serious injuries and 17 deaths associated with this issue. Additionally, Boston Scientific sent all affected customers a letter recommending they review IFU updates related to air embolism.

Additionally, the alert noted that risk of air embolism is acute in nature and limited to the duration of the implant procedure. Patients who have a previously implanted Watchman device do not require additional patient management and should continue to follow standard patient care at the discretion of their physician.

The complete FDA early alert with recommended actions is available online here.