EnVeo R Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014

Total Reports

486

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

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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.