EVOQUE Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024 · 6 device variants grouped

Total Reports

264

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Valve-Release Asystole Requiring Pacing

notification evoque, received notification, edwards received, report received, pod

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Increasing trendcritical

Regulatory

FDA recalls for this device

Class II

Mar 27, 2026 · Open, Classified

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Evidence

Related research

Cardiac Implantable Electronic Devices and Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Case-Review Series Highlighting Procedural and Management Considerations.

Guddeti RR, et al. · Structural heart : the journal of the Heart Team · 2025

Adverse Events Reported for the Evoque Transcatheter Tricuspid Valve Replacement

Lior Lupu, et al. · JACC: Cardiovascular Interventions · 2025

Successful implantation of an EVOQUE-tricuspid valve replacement system in a patient with two right ventricular implantable cardioverter-defibrillator leads: a case report.

Genske F, et al. · European heart journal. Case reports · 2025

Citations indexed from PubMed.

Keep exploring

Related devices in Structural

MitraClip

ABBOTT VASCULAR INC. · 19,068 reports

→

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Edwards Lifesciences LLC · 14,957 reports

→

Evolut FX

MEDTRONIC, INC. · 13,838 reports

→

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Edwards Lifesciences LLC · 10,561 reports

→

Evolut PRO

MEDTRONIC, INC. · 7,840 reports

→

WATCHMAN FLX

BOSTON SCIENTIFIC CORPORATION · 4,825 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. 1 active signal detected right now.

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.