EXOSEAL Adverse Events: FDA MAUDE Data
Cordis US Corp. · Vascular Hemostasis/Closure Device
Total Reports
371
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Deployment Button Failure with Indicator Issue
exoseal, indicator, vcd, window, exoseal vascular
32
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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
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. · Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2014
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. · Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2017
Exoseal for puncture site closure after antegrade procedures in peripheral arterial disease patients.
Hackl G, et al. · Diagnostic and interventional radiology (Ankara, Turkey) · 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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