Device evidence

device-recall:cfres:215347

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.

Official recall number

Z-2431-2025

Evidence summary

Product code: DQY
Recall status: Open, Classified
Event initiated: July 29, 2025
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2431-2025