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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Coronary Intervention
MAUDE LookupCoronary InterventionMYNXGRIP

MYNXGRIP Adverse Events: FDA MAUDE Data

Cordis US Corp. · Vascular Hemostasis/Closure Device · First cleared Aug 2005

Total Reports

1,209

Reports (30d)

25

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Closure Failure with Manual Compression Required

returned evaluation, device vcd, mynx control, mynx, sealant

39

reports

2

No Components Present in Device

terumo medical, medical corporation, corporation received, received following, angio seal

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

Disproportionate reportinghigh

Evidence

Related research

Endovascular foreign body removal of a MynxGrip polyethylene glycol (PEG) sealant embolus using a cerebral stent retriever.

Shamseldin M, et al. · 2021

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge.

Pruski MJ, et al. · 2017

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

MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study.

Ben-Dor I, et al. · 2018

MynxGrip vascular closure device use in pediatric neurointerventional procedures.

Shokuhfar T, et al. · 2018

Citations indexed from PubMed.

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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.