WATCHMAN TruSeal access systems recalled over air embolism during transseptal access
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
- Product
- WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
- Category
- Medical Device
- Distribution
- 0 states