EXOSEAL Adverse Events: FDA MAUDE Data
Cordis US Corp. · Vascular Hemostasis/Closure Device
Total Reports
469
Reports (30d)
45
Active Signals
4
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Indicator Window Failure to Change
exoseal, indicator, vcd, window, exoseal vascular
19
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
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
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
Comparison of Vascular Closure Devices vs Manual Compression After Femoral Artery Puncture in Patients on Oral Anticoagulation — Post Hoc Analysis of the ISAR-CLOSURE Trial
Katharina Mayer, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2021
Exoseal for puncture site closure after antegrade procedures in peripheral arterial disease patients.
Hackl G, et al. · Diagnostic and interventional radiology (Ankara, Turkey) · 2014
Citations indexed from PubMed.
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