Angio-Seal Adverse Events: FDA MAUDE Data

TERUMO MEDICAL CORPORATION · Vascular Hemostasis/Closure Device · First cleared Dec 1999 · 15 device variants grouped

Total Reports

6,417

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

Evidence

Related research

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

Ahrari A, et al. · 2023

A novel bailout technique using myocardial biopsy forceps to grasp a dislodged angio-seal collagen with footplate.

Miwa H, et al. · 2024

Predictors of Hemostasis Failure with Angio-Seal Device in a Real-World Setting for Infrainguinal Revascularization Procedures.

Alesiani F, et al. · 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

Dual ProGlide vs ProGlide and Angio-Seal for Femoral Access Hemostasis After Transcatheter Aortic Valve Replacement: A Randomised Comparative Trial

Chih‐Fan Yeh, et al. · Canadian Journal of Cardiology · 2024

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.