WATCHMAN FLX Pro Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Sep 2023 · 12 device variants grouped
Total Reports
2,911
Reports (30d)
80
Active Signals
0
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
74
reports
Pericardial Effusion Post-Deployment
effusion cardiac, tamponade, perforation, pericardiocentesis, effusion occurred
69
reports
Device Migration with Peri-Device Leak
wire, did seal, core wire, device leak, seal left
63
reports
Patient Death Following Procedure
events, long term, data, involved, death occurred
16
reports
Device Embolization Two Hours Post-Implant
air, attempts, curve, device embolization, embolized
13
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Direction-Controlled Retrieval of an Embolized Left Atrial Appendage Closure Device
Daisuke Ueshima, et al. · JACC Case Reports · 2026
Potential of a Novel Large Left Atrial Appendage Closure Device: Short‐Term Outcomes of the WATCHMAN FLX Pro 40‐mm Versus 35‐mm
Ryuki Chatani, et al. · Catheterization and Cardiovascular Interventions · 2025
A Randomized Controlled Trial Comparing the TruSteer and FXD Double Curve Delivery Systems for Left Atrial Appendage Occlusion With the Watchman FLX Pro Device—The GUIDE‐LAAO Study
Philippe Taieb, et al. · Catheterization and Cardiovascular Interventions · 2026
Evaluating the New Watchman FLX Pro 40 mm Device: A Case Study Series
Philippe Taieb, et al. · Catheterization and Cardiovascular Interventions · 2025
Antithrombotic therapy and device healing after left atrial appendage occlusion with Watchman FLX Pro: a single-center real-world cohort study
Maedeh Zokaei Nikoo, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2026
Citations indexed from PubMed.
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