TactiFlex Sensor EnabledRecalls & reported problems across all models

We found 8 models of TactiFlex Sensor Enabled by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 325 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2022 and Sep 29, 2026 — classified as 8 deaths, 136 injuries, 181 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (64 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TactiFlex Sensor Enabled recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 10, 2025Open, Classified

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

   Z-0113-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

2. 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 ↗

3. Sep 10, 2025Open, Classified

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

   Z-0111-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

4. Sep 10, 2025Open, Classified

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

   Z-0110-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

5. Sep 10, 2025Open, Classified

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

   Z-0109-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

6. 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 TactiFlex Sensor Enabled problems

TactiFlex Sensor Enabled models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TactiFlex™ Sensor Enabled™ A-TFSE-DF

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall6 deaths241 reports
• TactiFlex™ Sensor Enabled™ A-TFSE-FJ

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 recalls2 deaths37 reports
• TactiFlex™ Sensor Enabled™ A-TFSE-F

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall18 reports
• TactiFlex™ Sensor Enabled™ A-TFSE-DD

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall14 reports
• TactiFlex™ Sensor Enabled™ A-TFSE-D

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall12 reports
• TactiFlex™ Sensor Enabled™ A-TFSE-J

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 report
• TactiFlex™ Sensor Enabled™ A-TFSE-DF-X

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 report
• TactiFlex™ Sensor Enabled™ A-TFSE-FJ-X

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 report

Recent TactiFlex Sensor Enabled adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  During a pulmonary vein isolation atrial fibrillation procedure, the patient experienced ST elevation in the precordial leads after ablating with a TactiFlex SE catheter. After delivering ablation, two mics of Isuprel were administered to try to induce PVC's post-ablation. At this time, the patient began expressing discomfort and chest pain. Fentanyl was administered by anesthesia for the pain. It was noted that no obvious changes were observed, but upon review of the case slight ST elevation was noted in some of the precordial leads. During this point of the case, the physician looked at the LV on ICE and noted that the septal wall and apex of the left ventricle were no longer contracting. Cath lab physicians were called in and confirmed occlusion near the proximal ostia of the left anterior descending artery with contrast and fluoroscopy. During the cath portion of the procedure, the patient went into Ventricular Tachycardia and had to be shocked via external defibrillators. Intravascular ultrasound was brought in, and a dissection of the proximal left anterior descending artery was confirmed. A stent was placed, and the patient's septal wall of the left ventricle began contracti

  Patient problems: Arrhythmia; Vascular Dissection

  MAUDE report 50938840 ↗
• MalfunctionAug 24, 2026Material Separation

  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 when it was removed from the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408485 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  DURING A LEFT SIDED ATRIAL FLUTTER PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED. WHEN ATTEMPTING TO ABLATE ON THE LA ROOF, THE ABLATION CATHETER WAS OBSERVED OUTSIDE THE GEOMETRY. A FEW MINUTES LATER, HYPOTENSION OCCURRED. A PERICARDIAL EFFUSION WAS CONFIRMED WITH ECHO AND A PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS STOPPED. THE PATIENT WAS STABLE. THE PHYSICIAN ALLEGES THAT THE TACTIFLEX CAUSED THE PERICARDIAL EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24801241 ↗
• 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 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  DURING A TYPICAL FLUTTER PROCEDURE, A STEAM POP OCCURRED ON THE ISTHMUS, AND A PERICARDIAL EFFUSION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS. THE STEAM POP OCCURRED ON THE RIGHT ISTHMUS AT 40W AND THEN HYPOTENSION OCCURRED. A PERICARDIAL EFFUSION WAS NOTED WITH ULTRASOUND IMAGING. 600CC OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE. THE PHYSICIAN ALLEGES THE TACTIFLEX TO BE THE CAUSE FOR THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 24715416 ↗
• 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 10, 2026Material Separation

  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 WHEN IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560799 ↗
• MalfunctionMar 6, 2026Signal Artifact/Noise

  DURING THE AVNRT PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. THE SIGNAL QUALITY WAS POOR ON BOTH THE MAPPING SYSTEM AND THE NON-ABBOTT (CARDIOTEK) SYSTEM. THE CONNECTIONS AND THE CATHETER WERE INSPECTED, AND THE ENSITE X SYSTEM WAS RECONNECTED AND RESTARTED, ALONG WITH THE NON-ABBOTT (CARDIOTEK) SYSTEM, BUT THE SIGNAL QUALITY DID NOT IMPROVE. ELECTRICAL CONNECTIONS FOR THE ROOM, THE MAPPING SYSTEM, THE POLYGRAPH, AND OTHER EQUIPMENT WERE CHECKED, BUT THE ISSUE PERSISTED. BOTH THE CATHETER AND THE GENERATOR WERE REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537382 ↗
• 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 ↗
• MalfunctionMar 6, 2026Material Separation

  DURING PRE-USE INSPECTION FOR AN AF 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 24531025 ↗
• MalfunctionMar 4, 2026Material Separation

  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 WHEN IT WAS REMOVED FROM THE PATIENT. DURING THE ATRIAL FIBRILLATION PROCEDURE, THE CONTACT FORCE PARAMETERS WERE DISPLAYED IN PURPLE ON ENSITE. THE TACTISYS WAS RESTARTED, AND THE CATHETER CONNECTIONS WERE CHECKED, BUT THE ISSUE STILL REMAINED. 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 24511317 ↗
• MalfunctionFeb 27, 2026Material Separation

  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 WHEN IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475091 ↗
• MalfunctionFeb 27, 2026Material Separation

  DURING LEFT VENTRICLE ABLATION FOR VENTRICULAR TACHYCARDIA, THE ABLATION CATHETER HAD GOTTEN CAUGHT ON SOME CHORDAE REQUIRING SOME MANEUVERING TO REMOVE IT. THE AMPERE GENERATOR AND REMOTE BOTH READ AS 'CATHETER NOT CONNECTED'. WE WERE STILL ABLE TO READ INTERNAL EGMS, PACE, AND RECEIVE CONTACT FORCE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THE PROCEDURE CONCLUDED THE CATHETER WAS INSPECTED AND THE TIP WAS NO LONGER ATTACHED ON THE END. BOTH THE PHYSICIAN AND THE FELLOW WERE INFORMED THAT THE TIP HAD DETACHED. IT WAS SUSPECTED THAT THE TIP DID NOT DETACH WHILE INSIDE THE PATIENT, EGM READING AND CONTACT FORCE WERE STILL DISPLAYED DURING REMOVAL OF THE CATHETER. THERE WAS NO MENTION OF REMOVAL DIFFICULTY WHILE REMOVING THE CATHETER VIA THE INTRODUCER. NO FOREIGN BODY WAS NOTED ON FLUORO DURING THE INCIDENT. THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475085 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. WHILE PERFORMING BROCKENBROUGH, DIFFICULTY WAS NOTED AND SEVERAL ATTEMPTS WERE NEEDED TO ENTER THE LEFT ATRIUM. WHEN THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM AND MANIPULATED, THE CATHETER COULD NOT BE MANIPULATED AS EXPECTED. THE CATHETER WAS REMOVED FROM THE PATIENT, AND WHEN ATTEMPTING BROCKENBROUGH AGAIN, A DECREASE IN BLOOD PRESSURE WAS NOTED. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED NO PERICARDIAL EFFUSION, AND THERE WAS NO INCREASE IN THE HEART RATE, SO THE PATIENT WAS OBSERVED WITH VASOPRESSORS. THE BLOOD PRESSURE ROSE MOMENTARILY AND THEN GRADUALLY DECREASED, WHICH OCCURRED REPEATEDLY. EACH TIME THIS OCCURRED, AN ECHO WAS PERFORMED. AFTER A WHILE, PERICARDIAL EFFUSION WAS DIAGNOSED. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. IT SEEMED THAT SOMETHING HAD HAPPENED DURING BROCKENBROUGH. IT WAS CONSIDERED THAT THE ABBOTT DEVICES INCLUDING THE REPORTED DEVICE WERE NOT INVOLVED IN THE EVENT.

  Patient problems: Cardiac Perforation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449375 ↗
• MalfunctionFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, A CARDIAC PERFORATION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED. THE PVC PROCEDURE WAS IN BOTH THE LEFT AND RIGHT VENTRICLES. A NON-ABBOTT CS CATHETER (BIOSENSE) WAS PLACED AND ADVANCED ANTERIORLY TO SEE IF THERE WERE ANY EARLY VENTRICULAR SIGNALS. THE TACTIFLEX CATHETER WITH THE AGILIS SHEATH WERE INTRODUCED INTO THE RIGHT VENTRICLE TO MAP THE PVC BUT NO EARLY POINTS WERE FOUND. THUS, IT WAS DECIDED TO MAP THE LEFT VENTRICLE. THE LEFT VENTRICLE WAS ACCESSED VIA FEMORAL ARTERY. THE ABLATION CATHETER WAS THEN INTRODUCED INTO THE LEFT VENTRICLE AND IT WAS HARD TO GET TO THE TARGET AREA, SO IT WAS DECIDED TO GO TRANSSEPTAL TO ACCESS THE LEFT VENTRICLE. AFTER TRANSSEPTAL ACCESS, THE LEFT VENTRICLE WAS MAPPED, AND AN EARLY AREA WAS FOUND AND ABLATED. THE PVC WENT AWAY. A SECONDARY PVC WAS OBSERVED AND IT WAS DECIDED TO ATTEMPT TO FIND IT. THIS PVC WAS MAPPED ON THE RIGHT SIDE AND THEN THE LEFT. IT WAS DECIDED IT WAS A PERINODAL PVC ORIGINATING NEAR THE HIS. THE AORTIC CUSP AREA WAS ABOUT TO BE CHECKED FOR SIGNALS WHEN IT WAS NOTICED THAT THE PVC WAS GONE AND THE SINUS HEART RATE HAD INCREASED. USING ICE IT W

  Patient problems: Cardiac Perforation

  MAUDE report 24430592 ↗

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