Angio-Seal Adverse Events: FDA MAUDE Data
TERUMO MEDICAL CORPORATION · Vascular Hemostasis/Closure Device · First cleared Dec 1999 · 10 device variants grouped
Total Reports
6,727
Reports (30d)
72
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Failure with No Suture Present
loss, blood loss, angio, received following, angio seal
108
reports
Post-Procedure Bleed at Access Site
coronary, pressure, bleed, arterial, plug
10
reports
Device Cracked During Deployment Attempt
device vcd, mynx control, balloon, vcd, sealant
2
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
Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database
Aida Ahrari, et al. · Journal of Endovascular Therapy · 2023
Predictors of Hemostasis Failure with Angio-Seal Device in a Real-World Setting for Infrainguinal Revascularization Procedures
Francesca Alesiani, et al. · Annals of Vascular Surgery · 2025
A novel bailout technique using myocardial biopsy forceps to grasp a dislodged angio-seal collagen with footplate
Hiromi Miwa, et al. · CVIR Endovascular · 2024
Transaneurysmal Occlusion of Complicated Common Femoral Artery Pseudoaneurysms Using the Angio-Seal Closure Device—A Promising Technique
Timo Alexander Auer, et al. · CardioVascular and Interventional Radiology · 2022
Ultrasound-Guided vs Non–Ultrasound-Guided Angio-Seal Vascular Hemosasis After Endovascular Treatment for Peripheral Artery Disease: An Observational Study
Femke Anne Groenewegen, et al. · Journal of Endovascular Therapy · 2024
Citations indexed from PubMed.
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