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
2
Open Recalls
9
What the reports describe · Claripulse analysis
Most commonly reported problems
Communication Failure During Procedure
tactisys, completed adverse, procedural delay, tactiflex, ensite
6
reports
Pericardial Effusion Post-Ablation
pericardial effusion, pericardial, effusion, qdot, pericardiocentesis
2
reports
Irrigation Failure with Micro Catheter
micro catheter, qdot micro, flow, irrigation issue, qdot
1
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.
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