Evolut FX Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 14 device variants grouped

Total Reports

11,918

Reports (30d)

385

Active Signals

Open Recalls

Monthly Report Volume

No timeline data available.

Event Type Breakdown

No event type data available.

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate 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.

Evidence

Related research

Recapture technique for the surgical explantation of an infected self-expanding prosthesis after transcatheter aortic valve replacement prior to surgical aortic valve replacement

Koki Kurosaka, et al. · Interdisciplinary CardioVascular and Thoracic Surgery · 2025

Early experience with the Evolut FX self-expanding valve vs. Evolut PRO+ for patients with aortic stenosis undergoing TAVR

Ilan Merdler, et al. · Cardiovascular revascularization medicine · 2023

30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study

Hemal Gada, et al. · JACC: Cardiovascular Interventions · 2025

Transcatheter Aortic Valve Implantation Using the Evolut FX+ Platform With Optimal Diamond-Coronary Alignment

Joe Aoun, et al. · JACC Case Reports · 2024

Transcatheter Paravalvular Leak Closure Using Valve Frame Access.

Kharsa C, et al. · 2026

Citations indexed from PubMed.

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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.