WATCHMAN FLX Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Jul 2020 · 5 device variants grouped
Total Reports
2,585
Reports (30d)
5
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device-Related Thrombus at Follow-Up
thrombosis occurred, cerebral vascular, cerebral, accident, related thrombus
10
reports
Device Migration with Peri-Device Leak
wire, did seal, core wire, device leak, seal left
4
reports
Patient Death Following Procedure
events, long term, data, involved, death occurred
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices
Matthew J. Price, et al. · JACC: Cardiovascular Interventions · 2022
Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman
Matthew J. Price, et al. · JACC: Cardiovascular Interventions · 2025
Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry
Samir Ramesh Kapadia, et al. · Circulation Cardiovascular Interventions · 2024
Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study
Wei Zhou, et al. · EP Europace · 2026
Intracardiac echocardiography‐guided implantation of the Watchman FLX left atrial appendage closure device
Mohit K. Turagam, et al. · Journal of Cardiovascular Electrophysiology · 2021
Citations indexed from PubMed.
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