FARAWAVE Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Jan 2024 · 9 device variants grouped

Total Reports

4,555

Reports (30d)

183

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Jun 25, 2025 · Open, Classified

The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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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.