OCTARAY Mapping Catheter Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Intracardiac Mapping Catheter, High-Density · First cleared Jul 2020

Total Reports

151

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Irrigation Failure with Effusion Risk

sheath, octaray mapping, effusion, octaray, blood

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Telomere Length Is Associated With Adverse Atrial Remodeling in Patients With Atrial Fibrillation.

Pradhan K, et al. · 2025

Left Atrial Appendage Membrane in a Patient Presenting With Atrial Fibrillation.

Lee R, et al. · 2025

Cryoballoon Ablation of the Left Common Pulmonary Vein Using a Size-Adjustable Cryoballoon: A Comparative Study.

Arai H, et al. · 2025

Electrophysiological evaluation of incidental superior vena cava isolation following pulsed field ablation: a case report.

Hasegawa S, et al. · 2026

Citations indexed from PubMed.

Keep exploring

Related devices in EP Mapping

ACHIEVE

MEDTRONIC, INC. · 1,206 reports

→

PENTARAY NAV

Biosense Webster Inc · 549 reports

→

IntellaMap Orion

BOSTON SCIENTIFIC CORPORATION · 418 reports

→

Advisor HD Grid, Sensor Enabled

ABBOTT (ST. JUDE MEDICAL) · 408 reports

→

ACHIEVE ADVANCE

MEDTRONIC, INC. · 336 reports

→

DECANAV

Biosense Webster Inc · 122 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

Get Early Access

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.

→

How a safety signal is detected

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

→

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.