ExoSeal Adverse Events: FDA MAUDE Data
CORDIS CORPORATION · Vascular Hemostasis/Closure Device · First cleared Oct 2023 · 6 device variants grouped
Total Reports
2,494
Reports (30d)
88
Active Signals
3
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Indicator Failure Prevents Deployment
exoseal, indicator, exoseal vcd, sheath introducer, exoseal vascular
127
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
Use of the ExoSeal Vascular Closure Device in Patients With Peripheral Artery Disease: Risk Analysis of Deployment Failure and Prolonged Hemostasis
Ryo Okusako, et al. · Vascular and Endovascular Surgery · 2025
Safety and Efficacy of a Novel Sealant-Based Vascular Closure Device Following Electrophysiology Procedures: ReliaSeal Trial.
Summers J, et al. · Journal of cardiovascular electrophysiology · 2025
Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study
Anna Maria Ierardi, et al. · CardioVascular and Interventional Radiology · 2023
Citations indexed from PubMed.
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