WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide va...
FDA Recall #Z-2429-2025 — Class I — July 29, 2025
Product Description
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Reason for Recall
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.
Recalling Firm
Boston Scientific Corporation — Maple Grove, MN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
340185 units in total
Distribution
Worldwide.
Code Information
GTIN 00191506013820, ALL NON-EXPIRED BATCHES
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated