Recall Z-2434-2025— Boston Scientific Corporation

Name: FDA recall Z-2434-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-29

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2025-07-29. It names one FDA 510(k) clearance: K212228. Product: WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.. Reason: 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
Classification: Class I
Status: Ongoing
Initiated: 2025-07-29
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K212228 — WATCHMAN FXD Curve Access SystemBoston Scientific Corporation·cleared 2021-08-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.