Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
WATCHMAN TruSeal Access System SGL Recalled by Boston Scientific Corporation Due to Boston Scientific has identified a higher likelihood of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
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.
Quantity: 340185 units in total
Why Was This Recalled?
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 percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Where Was This Sold?
Worldwide.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report