Mynx Control Adverse Events: FDA MAUDE Data
CORDIS CORPORATION · Vascular Hemostasis/Closure Device · First cleared Aug 2005 · 4 device variants grouped
Total Reports
2,959
Reports (30d)
139
Active Signals
3
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Sealant Failure During Deployment
control vascular, mynx control, balloon, verified, sealant
159
reports
Post-Deployment Hematoma Development
control venous, access sites, mynx control, venous vascular, sites
43
reports
Post-Deployment Groin Infection
returned evaluation, control venous, mynx control, venous vascular, sites
25
reports
Post-Deployment Groin Swelling
evaluation reported, control venous, mynx control, venous vascular, sites
20
reports
Locator Kink Prevents Deployment
loss, blood loss, angio, received following, angio seal
1
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
Regulatory
FDA recalls for this device
Nov 28, 2023 · Open, Classified
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
Nov 28, 2023 · Open, Classified
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
Evidence
Related research
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
Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study.
Diamantopoulos A, et al. · Vascular · 2021
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. · Journal of clinical medicine · 2023
Utilisation of Image Guidance to Enhance Safety of Deployment of the Mynx Control Vascular Closure Device.
Dolan SG, et al. · Vascular and endovascular surgery · 2021
Ayman O, et al. · CVIR endovascular · 2025
Citations indexed from PubMed.
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