MYNX CONTROL VCD 6F7F Adverse Events: FDA MAUDE Data

CORDIS CORPORATION · Vascular Hemostasis/Closure Device

Total Reports

117

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

No timeline data available.

Event Type Breakdown

No event type data available.

Regulatory

FDA recalls for this device

Class II

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.

Class II

Nov 28, 2023 · Open, Classified

Keep exploring

Related devices in Coronary

Perclose ProGlide

ABBOTT VASCULAR INC. · 24,504 reports

→

Perclose ProStyle

ABBOTT VASCULAR INC. · 19,336 reports

→

PERCLOSE

ABBOTT VASCULAR INC. · 9,890 reports

→

Angio-Seal

TERUMO MEDICAL CORPORATION · 6,417 reports

→

SYNERGY

BOSTON SCIENTIFIC CORPORATION · 5,991 reports

→

Resolute Onyx

MEDTRONIC, INC. · 4,467 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

Get Early Access

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.

→

How a safety signal is detected

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

→

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.