OptiCross 6 HD Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Jan 2022

Total Reports

209

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Mar 5, 2024 · Open, Classified

Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

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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.