WATCHMAN FLX Pro Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015

Total Reports

710

Reports (30d)

22

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Device-Related Thrombus Post-Implant

performed watchman, flx, wds, flx pro, watchman flx

89

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Active safety signals

Disproportionate reportinghigh

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.