TactiFlex™ Sensor Enabled™ A-TFSE-FJRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05415067034618), received between Jan 10, 2024 and Mar 10, 2026 — classified as 2 deaths, 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (11 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 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 16, 2026.

Recalls naming this device

1. Sep 10, 2025Open, Classified

   Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

   Z-0112-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

2. Dec 18, 2023Open, 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.

   Z-0814-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Separation; Communication or Transmission Problem

  UPON PRODUCT INVESTIGATION, THE DISTAL TIP OF THE CATHETER WAS NOTED TO BE DETACHED, HOWEVER FURTHER INFORMATION RECEIVED FROM THE FIELD CONFIRMED THAT THE CATHETER WAS INTACT DURING DEVICE PREPARATION AND NEVER MADE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560987 ↗
• MalfunctionMar 6, 2026Material Separation

  DURING PRE-USE INSPECTION FOR AN SVT PROCEDURE, THE CATHETER TIP WAS FOUND TO BE FRACTURED AND DETACHED PRIOR TO PATIENT CONTACT. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531030 ↗
• MalfunctionFeb 19, 2026Connection Problem

  THIS REPORT INCLUDES CORRECTED DEVICE MANUFACTURING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387857 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  AFTER THE REDO ATRIAL FIBRILLATION PROCEDURE WAS COMPLETED, A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED WHICH NOTED AN ABSENCE OF NORMAL CARDIAC SILHOUETTE MOVEMENT DUE TO A PERICARDIAL TAMPONADE. THIS RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED. THE PATIENT BECAME HEMODYNAMICALLY STABLE. THE EXACT CAUSE OF THE TAMPONADE COULD NOT BE CLEARLY IDENTIFIED. DURING THE PROCEDURE, THERE WAS NO EXCESSIVE CONTACT FORCE OR ABNORMAL IMPEDANCE BEHAVIOR OBSERVED DURING RF ABLATIONS. THE ABLATION POWER SETTINGS WAS AT 50W. AS THIS WAS A REDO PROCEDURE, ABLATION WAS CARRIED OUT AT THE SUPERIOR VENA CAVA, ALONG THE LEFT SUPERIOR PULMONARY VEIN IN THE RIDGE AREA, AND THE RIGHT PULMONARY VEIN ANTRUM WAS WIDENED ON THE ANTERIOR ASPECT. THE LOCATION OF THE PERFORATION IS UNKNOWN. THE PATIENT IS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24151608 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. WHILE ADVANCING THE CATHETER INTO THE LEFT VENTRICLE, A DROP IN BLOOD PRESSURE AND POOR CONTRACTILITY IN THE CARDIAC SILHOUETTE WAS OBSERVED. FLUOROSCOPY AND AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PERFORATION WAS LOCATED IN THE AV GROOVE. THERE WAS NO PERFORMANCE ISSUE WITH ANY ABBOTT DEVICE. THE PHYSICIAN IS UNSURE WHAT CAUSED THE TAMPONADE.

  Patient problems: Cardiac Perforation

  MAUDE report 23896005 ↗
• MalfunctionNov 5, 2025Use of Device Problem; Use of Device Problem

  DURING THE CAVO-TRICUSPID ISTHMUS PROCEDURE, THE ABLATION CATHETER WAS USED PAST ITS EXPIRATION DATE. THE ABLATION CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480612 ↗
• MalfunctionSep 18, 2025Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE ABLATION CATHETER WOULD NOT DISPLAY CONTACT FORCE. THE DEVICE WAS REPLACED, HOWEVER THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083747 ↗
• MalfunctionSep 9, 2025Optical Problem; Optical Problem

  THE CATHETER WOULD NOT DISPLAY CONTACT FORCE AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006194 ↗
• MalfunctionAug 27, 2025Use of Device Problem; Use of Device Problem

  THIS REPORT IS TO ADVISE OF AN EXPIRED CATHETER USED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904756 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE NIGHT FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION WAS DIAGNOSED BY ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE CAUSE OF THE PERICARDIAL EFFUSION IS UNKNOWN.

  Patient problems: Cardiac Perforation

  MAUDE report 22542436 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REDO ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION REQUIRING SURGERY TO RESOLVE. ABLATION WAS BEING PERFORMED ON THE INFERIOR ASPECT OF THE LIPV AND WHEN REACHING THE RIDGE, THE PATIENT BECAME HYPOTENSIVE. USING THE ICE CATHETER A PERICARDIAL EFFUSION AND A PERFORATION AT THE ANTERIOR SIDE OF THE LEFT ATRIAL APPENDAGE WAS CONFIRMED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS MOVED TO THE CORONARY UNIT TO BE MONITORED. HOURS LATER, THE BLEEDING HAD NOT STOPPED, SO THE PATIENT WAS TAKEN BACK FOR CARDIAC SURGERY. THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22511608 ↗
• DeathJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE MONTH FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPIRED DUE TO AN ESOPHAGEAL FISTULA. CAUSES AND CONTRIBUTING FACTORS ARE CURRENTLY UNKNOWN AND THERE HAS BEEN NO ALLEGED DEVICE INVOLVEMENT.

  Patient problems: Perforation of Esophagus

  MAUDE report 22501494 ↗
• DeathJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. AT THE END OF ABLATION THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND CONFIRMED THE EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED STABILIZING THE PATIENT. THE PATIENT BECAME HYPOTENSIVE ONCE AGAIN A FEW MINUTES LATER AND CARDIAC MASSAGE WAS ATTEMPTED, HOWEVER, THE PATIENT EXPIRED. IT IS ALLEGED THAT THE PERICARDIAL EFFUSION MOST LIKELY OCCURRED DURING ABLATION WITH THE ABLATION CATHETER. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22298988 ↗
• MalfunctionJun 6, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159670 ↗
• MalfunctionApr 3, 2025Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA WITH ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THE CATHETER FIBER OPTICS DID NOT DISPLAY CONTACT FORCE RESULTING IN A DELAY. THE TACISYS AND THE FIBER OPTICS CABLE WERE EXCHANGED, AND THE AMPERE GENERATOR WAS RESTARTED, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759357 ↗
• MalfunctionMar 24, 2025

  ABLATION CATHETER STOPPED FLUSHING/REMOVED CATHETER AND OPENED NEW ABLATION CATHETER. NEW CATHETER WORKED PERFECTLY.

  Patient problems: Insufficient Information

  MAUDE report 21676063 ↗
• MalfunctionDec 2, 2024Optical Problem; Optical Problem

  DURING A TYPICAL FLUTTER PROCEDURE, THE CATHETER DISPLAYED CONTACT FORCE ABOVE 100G RESULTING IN CANCELLATION OF THE PROCEDURE. THE CATHETER WAS RE-ZEROED, BUT ONCE IT MADE CONTACT WITH TISSUE, THE FORCE JUMPED TO OVER 100G. THE ISSUE WAS NOT RESOLVED, AND THE PROCEDURE WAS CANCELLED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20823621 ↗
• MalfunctionNov 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RELATED MANUFACTURE REF: 3008452825-2024-00664. DURING AN ATRIAL FIBRILLATION PROCEDURE, AN OUTPUT ISSUE OCCURRED CAUSING A DELAY IN PROCEDURE. IT WAS NOTED THAT THERE WAS NO RF DELIVERY DURING ABLATION. THE TACTISYS CABLE AND AMPERE AMPLIFIER CABLE WERE EXCHANGED, AS WELL AS EXCHANGING THE TACTISYS AND GENERATOR WHICH DID NOT RESOLVE THE ISSUE. A SECOND CATHETER WAS OBTAINED, BUT IT COULD NOT BE VISUALIZED DESPITE SIGNALS BEING PRESENT. ADDITIONALLY, IT DISPLAYED A STRANGE SHAPE WHILE IN NAVX MODE. A THIRD CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693930 ↗
• MalfunctionNov 15, 2024Failure to Deliver Energy; Failure to Deliver Energy

  RELATED MANUFACTURE REF: 3008452825-2024-00665. DURING AN ATRIAL FIBRILLATION PROCEDURE, AN OUTPUT ISSUE OCCURRED CAUSING A DELAY IN PROCEDURE. IT WAS NOTED THAT THERE WAS NO RF DELIVERY DURING ABLATION. THE TACTISYS CABLE AND AMPERE AMPLIFIER CABLE WERE EXCHANGED, AS WELL AS EXCHANGING THE TACTISYS AND GENERATOR WHICH DID NOT RESOLVE THE ISSUE. A SECOND CATHETER WAS OBTAINED, BUT IT COULD NOT BE VISUALIZED DESPITE SIGNALS BEING PRESENT. ADDITIONALLY, IT DISPLAYED A STRANGE SHAPE WHILE IN NAVX MODE. A THIRD CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693919 ↗
• InjuryNov 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ABLATION OF THE CTI LINE IN THE RIGHT ATRIUM, A STEAM POP AND EFFUSION OCCURRED. WHILE ABLATING WITH 20W ON THE CAVO TRICUSPID ISTHMUS FOR 30 SEC EACH LESION, THE USER WAS UNABLE TO ACHIEVE BLOCK THE FIRST TIME AROUND, SO THE POWER WAS INCREASED TO 40W AND ABLATING AN AREA OF BREAKTHROUGH. AN AUDIBLE ¿POP¿ WAS HEARD, IMPEDANCE ROSE INSTANTLY FROM 105 OHMS TO 122 AND ABLATION WAS STOPPED. THE PATIENT THEN DEVELOPED AN EFFUSION AND INTERVENTION WAS APPLIED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 20599488 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED REQUIRING A PERICARDIOCENTESIS. AFTER ABLATION, AN APPENDIX OCCLUSION PROCEDURE WAS PERFORMED. AT THE END OF THE APPENDIX OCCLUSION PROCEDURE, WHEN THE PUNCTURE COMPRESSION WAS BEING PERFORMED, EVIDENCE OF A CARDIAC TAMPONADE WAS IDENTIFIED. A PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT REMAINED STABLE WITHOUT FURTHER COMPLICATIONS. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20588502 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT-SIDED ATRIAL TACHYCARDIA PROCEDURE, THE PHYSICIAN WAS APPLYING RADIOFREQUENCY WITH TACTIFLEX. WHEN THE PROCEDURE WAS ABOUT TO FINISH, CARDIAC TAMPONADE OCCURRED DUE TO THE ABLATION AND THE PATIENT HAD TO BE TREATED. PATIENT IS CURRENTLY STABLE. CATHETER WAS DISCARDED.

  Patient problems: Cardiac Perforation

  MAUDE report 20482207 ↗
• MalfunctionJun 13, 2024Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531161 ↗
• MalfunctionMay 3, 2024Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238399 ↗
• MalfunctionApr 17, 2024Communication or Transmission Problem; Impedance Problem; Communication or Transmission Problem; Impedance Problem

  DURING A RIGHT ATRIAL FLUTTER PROCEDURE, AN ERROR MESSAGE OCCURRED CAUSING A PROCEDURE DELAY. THE CATHETER WAS CONNECTED TO THE GENERATOR WITH AN IMPEDANCE READING OF APPROXIMATELY 100 OHMS, AND AN ERROR MESSAGE WAS NOTED STATING: "CATHETER NOT CONNECTED". THIS ERROR APPEARED WITH TWO DIFFERENT AMPERE GENERATORS. THE CATHETER WAS EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE TACTIFLEX CATHETER WAS REPLACED WITH A TACTICATH SE BUT THE ISSUE WAS NOT RESOLVED. THE ENSITE X WAS THEN SWITCHED TO ENSITE PRECISION, WHICH RESOLVED THE ISSUE WITH NO CONSEQUENCES TO THE PATIENT. IT SHOULD BE NOTED THAT THE ENSITE X HAS BEEN USED SINCE WITH NO ISSUES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124339 ↗

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-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