WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Recall Insight

This FDA Devices action (record #Z-2430-2025) was formally reported on September 10, 2025, with the manufacturer initiating the action on July 29, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Maple Grove, MN. Federal records indicate 340185 units in total units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percuta… Distribution data in the federal record shows the product reached: Worldwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.