TactiFlex™ Sensor Enabled™ A-TFSE-FJ-XRecalls & reported problems

St. Jude Medical, Inc. · Ablation Catheter · Class 3

All models of TactiFlex Sensor Enabled (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067052018), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (1 report).

5 other recalls cover devices cleared under the same FDA submission (P220013); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Signal Artifact/Noise1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 31, 2026Signal Artifact/Noise
DURING A TYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A NOISE ISSUE. ELECTRODE 3 ON THE CATHETER WAS NOISY AND DID NOT DISPLAY AS EXPECTED ON THE MAPPING SYSTEM. THE CATHETER, GENERATOR AND TACTISYS CABLES WERE ALL RECONNECTED WITH NO RESOLUTION. THE MOLEX CABLE, RF CABLE, AND TACTISYS WERE REPLACED WITH NO RESOLUTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749126 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P220013. One submission often covers many models, so check the product and lot details in each record.

Z-0113-2026 · Sep 10, 2025 · Open, Classified
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Z-0110-2026 · Sep 10, 2025 · Open, Classified
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Z-0111-2026 · Sep 10, 2025 · Open, Classified
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Z-0112-2026 · Sep 10, 2025 · Open, Classified
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Z-0109-2026 · Sep 10, 2025 · Open, Classified
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

Device details

UDI-DI	`05415067052018`
Brand	TactiFlex™ Sensor Enabled™
Model	A-TFSE-FJ-X
Company	St. Jude Medical, Inc.
Product code	OAE · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Class	Class 3
FDA submission	P220013
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 6, 2025

Device type (GMDN): Cardiac radio-frequency ablation system catheter

A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

Other Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation devices

TactiCath™ A-TCSE-DF
St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
1 recall23 deaths923 reports
TactiCath™ PN-004075
St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
7 deaths338 reports
TactiFlex™ Sensor Enabled™ A-TFSE-DF
St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
1 recall6 deaths241 reports
TactiCath™ A-TCSE-FJ
St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
1 recall3 deaths174 reports
Sphere-9™ Catheter AFR-00001
Medtronic, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
1 recall3 deaths147 reports
TactiCath™ A-TCSE-D
St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
2 deaths175 reports
TactiSys™ PN-004400
St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
1 recall125 reports
QDOT MICRO D139402
Biosense Webster Inc · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
3 deaths171 reports

All Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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