TactiSys Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared May 2021 · 7 device variants grouped
Total Reports
156
Reports (30d)
0
Active Signals
0
Open Recalls
6
What the reports describe · Claripulse analysis
Most commonly reported problems
Contact Force Display Failure During Procedure
tactisys, exchanged, tactiflex catheter, contact force, consequences
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Effects of Contact Force on Lesion Size During Pulsed Field Catheter Ablation: Histochemical Characterization of Ventricular Lesion Boundaries
Hiroshi Nakagawa, et al. · Circulation Arrhythmia and Electrophysiology · 2023
Force-Sensing Catheters During Pediatric Radiofrequency Ablation: The FEDERATION Study.
Dalal AS, et al. · Journal of the American Heart Association · 2017
Citations indexed from PubMed.
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