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FDA Issues Early Alert on Boston Scientific’s Watchman Access System - Cardiac Interventions Today
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FDA Issues Early Alert on Boston Scientific’s Watchman Access System - Cardiac Interventions Today
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 …
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