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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Coronary Intervention
MAUDE LookupCoronary InterventionMYNX CONTROL

MYNX CONTROL Adverse Events: FDA MAUDE Data

Cordis US Corp. · Vascular Hemostasis/Closure Device · First cleared Aug 2005

Total Reports

261

Reports (30d)

9

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Closure Failure with Manual Compression Required

returned evaluation, device vcd, mynx control, mynx, sealant

20

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System.

Noory E, et al. · 2023

Imaging-Guided Deployment of a Balloon-Based Vascular Closure Device in Routine Clinical Practice.

Lee WH, et al. · 2022

Utilisation of Image Guidance to Enhance Safety of Deployment of the Mynx Control Vascular Closure Device.

Dolan SG, et al. · 2021

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.