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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Coronary Intervention
MAUDE LookupCoronary InterventionEXOSEAL

EXOSEAL Adverse Events: FDA MAUDE Data

Cordis US Corp. · Vascular Hemostasis/Closure Device

Total Reports

365

Reports (30d)

15

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Indicator Window Failure to Change

exoseal, indicator, exoseal vcd, vcd, exoseal vascular

59

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

Use of the ExoSeal Vascular Closure Device in Patients With Peripheral Artery Disease: Risk Analysis of Deployment Failure and Prolonged Hemostasis

Ryo Okusako, et al. · Vascular and Endovascular Surgery · 2025

Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths.

Goto S, et al. · 2017

Balloon-assisted ExoSeal closure for inadvertent subclavian artery cannulation following central venous catheterization: A case report

Yu Wang, et al. · Science Progress · 2025

Safety and effectiveness of a novel vascular closure device: a prospective study of the ExoSeal compared to the Angio-Seal and ProGlide.

Kara K, et al. · 2014

Efficacy and Safety of Ultrasound-Guided Repeat Access and Repeat Closure With an ExoSeal Vascular Closure System in Patients With Peripheral Arterial Disease

Taira Kobayashi, et al. · Vascular and Endovascular Surgery · 2021

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.