MynxGrip Adverse Events: FDA MAUDE Data
CORDIS CORPORATION · Vascular Hemostasis/Closure Device · First cleared Aug 2005 · 3 device variants grouped
Total Reports
2,740
Reports (30d)
42
Active Signals
2
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Sealant Failure During Deployment
control vascular, mynx control, balloon, verified, sealant
70
reports
Post-Deployment Hematoma Development
control venous, access sites, mynx control, venous vascular, sites
2
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
Endovascular foreign body removal of a MynxGrip polyethylene glycol (PEG) sealant embolus using a cerebral stent retriever
Mohammed Shamseldin, et al. · CVIR Endovascular · 2021
MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge.
Pruski MJ, et al. · Vascular and endovascular surgery · 2017
Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial
Lars Jakobsen, et al. · BMC Cardiovascular Disorders · 2022
Use of the MynxGrip vascular closure device in patients undergoing interventional diagnosis or treatment: The PANDA multicenter, open-label, randomized controlled trial
Ligang Song, et al. · The Journal of Vascular Access · 2023
Hemostasis After Brachial Artery Access With the MynxGrip Device: A Case Report.
Giordano A, et al. · Clinical Medicine Insights. Cardiology · 2018
Citations indexed from PubMed.
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