The FDA has issued an alert about a potentially high-risk issue involving models of Boston Scientific’s Watchman Access Systems, which are used to provide vascular and transseptal access during implantation of left atrial appendage closure devices.
The alert comes after Boston Scientific sent a letter July 30 to affected customers, recommending updates to instructions for use due to risk of air embolism during procedures, according to an Aug. 6 FDA news release
The devicemaker found a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.
Boston Scientific reported 120 serious injuries and 17 deaths.
