FDA (Devices) recall action 97363

Boston Scientific Corporation recalled 11 products on 2025-09-10

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2025-09-10
Critical: 11
Units: 3,742,035

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

CriticalFDA (Devices)··2025-09-10
TruSeal ANT access systems recalled over air embolism risk without controlled ventilation
Boston Scientific is recalling WATCHMAN TruSeal Access System ANT after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
Transseptal access systems recalled over higher air embolism risk without controlled ventilation
Boston Scientific is recalling WATCHMAN TruSeal Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. 340,185 units are affected.
Product
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
TruSteer transseptal access systems recalled over higher air embolism risk
Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
FXD Curve access systems recalled over ventilation-related air embolism risk
Boston Scientific is recalling WATCHMAN FXD Curve Access Sys Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
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.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
FXD Curve single access systems recalled over air embolism likelihood
Boston Scientific is recalling WATCHMAN FXD Curve Access System Sgl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
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.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
FXD Curve access systems recalled over air embolism risk during transseptal procedures
Boston Scientific is recalling WATCHMAN FXD Curve Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
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.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
TruSeal double access systems recalled over air embolism risk under sedation
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
TruSeal single access systems recalled over transseptal air ingress risk
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, OUS, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
WATCHMAN TruSeal access systems recalled over air embolism during transseptal access
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
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.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
FXD Curve double access systems recalled over transseptal air embolism risk
Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Category
Distribution
0 states
CriticalFDA (Devices)··2025-09-10
TruSeal DBL access systems recalled over air embolism risk without ventilation
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Distribution
0 states