|
|
|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
|
Z-2426-2025 - 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 Sys...
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2427-2025 - 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 Sys...
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2428-2025 - 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 Sys...
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2429-2025 - 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.
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2430-2025 - 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.
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2436-2025 - 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.
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2432-2025 - 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 Syst...
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2433-2025 - 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 Syst...
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2434-2025 - 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.
|
1
|
08/29/2025
|
Boston Scientific Corporation
|
|
Z-2435-2025 - 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.
|
1
|
08/29/2025
|
Boston Scientific Corporation
|