OptiCross 18 Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Sep 2022 · 2 device variants grouped

Total Reports

221

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Imaging Catheter Tip Blockage

opticross imaging, examination target, issue occurred, imaging catheter, opticross

reports

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

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.

Evidence

Related research

Intravascular Ultrasound–Guided or Angiography-Guided Complex High-Risk PCI

Roberto Diletti, et al. · New England Journal of Medicine · 2026

Intravascular Ultrasound Guided Intervention in Calcified Coronary Lesions Showed Good Clinical Outcomes during One Year Follow-Up

Khanh-Hung Doan, et al. · Journal of Clinical Medicine · 2023

Association of Attenuated Plaques Detected by Intravascular Ultrasound With Plaque Calcification Assessed by Computed Tomography Angiography

Yang Zhao, et al. · Reviews in Cardiovascular Medicine · 2026

Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Antonio Mangieri, et al. · Catheterization and Cardiovascular Interventions · 2023

Wańha W, et al. · Journal of clinical medicine · 2022

Citations indexed from PubMed.

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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.