MYNX CONTROL VENOUS Vascular Closure Device 6F-12F Adverse Events: FDA MAUDE Data
CORDIS CORPORATION · Vascular Hemostasis/Closure Device · First cleared Aug 2005
Total Reports
1,142
Reports (30d)
36
Active Signals
0
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Cracked During Deployment Attempt
device vcd, mynx control, balloon, vcd, sealant
39
reports
Infection at Venous Access Sites
control venous, venous, mynx control, venous vascular, sites
17
reports
DVT and PE Post-Closure Device Use
control venous, venous, mynx control, venous vascular, vcd
16
reports
Localized Reaction at Venous Access Sites
control venous, days, mynx control, venous vascular, sites
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Citations indexed from PubMed.
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