Boston Scientific Updates Watchman Device Implant Guidelines to Address Safety Risk

Boston Scientific has revised the instructions for use of its FXD Curve, Truseal, and Trusteer access systems for Watchman heart device implantation, following reports of 120 serious injuries and 17 deaths. The FDA issued an alert, noting that performing the procedure without controlled ventilation can allow air bubbles to enter the bloodstream, potentially causing arrhythmia, stroke, organ failure, or hemodynamic collapse.

The risk occurs only during implantation, particularly in sedated patients who are not on ventilators. Literature shows sedation can triple the risk of negative heart pressure and air entry, especially in patients with low atrial pressure, severe fluid loss, or partial airway collapse.

Boston Scientific advises mitigating risks by ensuring patients are not hypovolemic, positioning the access valve below heart level, and timing device exchanges during exhalation. The Watchman line remains a strong growth driver, with U.S. sales up 28% in Q2 and plans for global expansion.

10-08-2025