TactiFlex Sensor Enabled Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared May 2023 · 16 device variants grouped
Total Reports
525
Reports (30d)
10
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
13
reports
Post-Ablation Pericardial Effusion and Tamponade
micro, qdot micro, pericardial, effusion, qdot
4
reports
Irrigation Delivery Issue with Catheter
pebax, qdot micro, patient underwent, qdot, index
3
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
The missing vector - TactiFlex sensor enabled ablation catheter.
Kewcharoen J, et al. · Pacing and clinical electrophysiology : PACE · 2023
Safe and effective delivery of high-power, short-duration radiofrequency ablation lesions with a flexible-tip ablation catheter
Leon M. Ptaszek, et al. · Heart Rhythm O2 · 2022
Efficacy of a Novel Ablation Index Algorithm for Cavotricuspid Isthmus Ablation Using a Flexible-Tip Ablation Catheter.
Sudo K, et al. · Journal of arrhythmia · 2026
Comparison of very high-power short-duration and ablation index guided catheter ablation for cavotricuspid isthmus block
Bettina Kirstein, et al. · Journal of Interventional Cardiac Electrophysiology · 2026
Citations indexed from PubMed.
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