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TactiCath Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Apr 2025

Total Reports

1,048

Reports (30d)

0

Active Signals

1

Open Recalls

9

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Increasing trendmedium

Regulatory

FDA recalls for this device

Class I

Sep 10, 2025 · Open, Classified

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Class I

Sep 10, 2025 · Open, Classified

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Class I

Sep 10, 2025 · Open, Classified

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Class I

Sep 10, 2025 · Open, Classified

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Class I

Sep 10, 2025 · Open, Classified

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Class II

Dec 18, 2023 · Open, Classified

When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.

Evidence

Related research

Safety verification of a novel irrigation catheter with flexible tip of laser‐cut kerfs and contact force sensor

Junji Yamaguchi, et al. · Pacing and Clinical Electrophysiology · 2023

Ablation outcomes in children with Mahaim tachycardia using the TactiCath contact force catheter

Şevket Ballı, et al. · Cardiology in the Young · 2026

Acute procedural safety of the latest radiofrequency ablation catheters in atrial fibrillation ablation: Data from a large prospective ablation registry

Hirofumi Arai, et al. · Journal of Cardiovascular Electrophysiology · 2024

Characteristics of tissue temperature during ablation with THERMOCOOL SMARTTOUCH SF versus TactiCath versus QDOT MICRO catheters (Qmode and Qmode+): An in vivo porcine study

Naoto Otsuka, et al. · Journal of Cardiovascular Electrophysiology · 2023

Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results

Ante Anić, et al. · EP Europace · 2023

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.

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.