Angio-Seal Adverse Events: FDA MAUDE Data
TERUMO MEDICAL CORPORATION · Vascular Hemostasis/Closure Device · First cleared Dec 1999 · 10 device variants grouped
Total Reports
6,783
Reports (30d)
55
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Locator Kink Prevents Deployment
loss, blood loss, angio, received following, angio seal
92
reports
Sealant Failure During Deployment
control vascular, mynx control, balloon, verified, sealant
8
reports
Suture Break During Arteriotomy Closure
provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device
1
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
A novel bailout technique using myocardial biopsy forceps to grasp a dislodged angio-seal collagen with footplate
Hiromi Miwa, et al. · CVIR Endovascular · 2024
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
Shattered by Light: Catheter Fractures and the Hidden Danger of Angio-Seal Device Failure in the Femoral Artery
Rouzbeh Kotaki, et al. · Vascular and Endovascular Surgery · 2025
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
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
Citations indexed from PubMed.
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