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TactiFlex Sensor Enabled Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared May 2023

Total Reports

330

Reports (30d)

7

Active Signals

0

Open Recalls

9

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Cardiac Tamponade from Micro Catheter Use

micro catheter, micro, qdot micro, used, qdot

12

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

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.

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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.