MYNX CONTROL Adverse Events: FDA MAUDE Data
Cordis US Corp. · Vascular Hemostasis/Closure Device
Total Reports
829
Reports (30d)
91
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Cracked During Deployment Attempt
device vcd, mynx control, balloon, vcd, sealant
72
reports
DVT and PE Post-Closure Device Use
control venous, venous, mynx control, venous vascular, vcd
18
reports
Infection at Venous Access Sites
control venous, venous, mynx control, venous vascular, sites
8
reports
Localized Reaction at Venous Access Sites
control venous, days, mynx control, venous vascular, sites
5
reports
Suture Break During Knot Advancement
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
Summers J, et al. · Journal of cardiovascular electrophysiology · 2025
Success Rate and Proposed Mechanism of Balloon Rupture in Hemostasis With MYNX CONTROL
Kaido Kobayashi, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2026
Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study
Αθανάσιος Διαμαντόπουλος, et al. · Vascular · 2021
Assessing the MYNX CONTROL arterial vascular closure device after catheterization procedures that enter the body through the femoral arteries
Alexia Goulianou, et al. · Expert Review of Medical Devices · 2026
Utilisation of Image Guidance to Enhance Safety of Deployment of the Mynx Control Vascular Closure Device
Steven G. Dolan, et al. · Vascular and Endovascular Surgery · 2021
Citations indexed from PubMed.
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