TactiCath Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Apr 2025 · 10 device variants grouped
Total Reports
2,367
Reports (30d)
7
Active Signals
2
Open Recalls
6
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Ablation Pericardial Effusion and Tamponade
micro, qdot micro, pericardial, effusion, qdot
4
reports
Contact Force Display Failure During Procedure
tactisys, exchanged, tactiflex catheter, contact force, consequences
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Sep 10, 2025 · Open, Classified
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Sep 10, 2025 · Open, Classified
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Sep 10, 2025 · Open, Classified
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Sep 10, 2025 · Open, Classified
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Sep 10, 2025 · Open, Classified
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
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
Pulsed Field Ablation for the Treatment of Ventricular Arrhythmias Using a Focal, Contact-Force Sensing Catheter: A Single-Center Case Series and Review
Cristian Martignani, et al. · Journal of Cardiovascular Development and Disease · 2026
Focal monopolar pulsed field ablation for focal right atrial tachycardia: feasibility and safety from a single-centre experience
A Keelani, et al. · EP Europace · 2026
Citations indexed from PubMed.
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