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

Summary

The FDA's MAUDE database contains 241 adverse event reports that list this exact device (DI 05415067034571), received between Nov 7, 2022 and Aug 24, 2026 — classified as 6 deaths, 102 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (47 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 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-0111-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 241 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 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

  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 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA, A PERICARDIAL EFFUSION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED AND OPEN-HEART SURGERY. THE PATIENT HAD A LEFT LATERAL PATHWAY SO A TRANSSEPTAL APPROACH WAS PERFORMED. THE TACTIFLEX CATHETER WAS ADVANCED TO THE LEFT ATRIUM AND THE PATHWAY WAS MAPPED TO THE MOST LATERAL ASPECT OF THE MITRAL VALVE. AFTER ABLATION, THE PATIENT'S BLOOD PRESSURE DROPPED AND RESPIRATIONS BECAME SHALLOW. ICE WAS REVIEWED AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND SOME BLOOD WAS EXTRACTED BUT THE PATIENT'S BLOOD PRESSURE AND RESPIRATIONS DID NOT RESPOND. OPEN-HEART SURGERY WAS THEN ELECTED TO BE PERFORMED. THE PATIENT WAS THEN SENT TO THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24423277 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, HYPOTENSION OCCURRED ASSOCIATED WITH ST ELEVATION, FOLLOWED BY PEA WITH A TRANSIENT RESPONSE TO INOTROPIC SUPPORT WHICH RESULTED IN RESUSCITATION BEING PERFORMED AND PLACEMENT OF A VA-ECMO, AND A CORONARY SPASM TREATED WITH NITRATES. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA IN THE SETTING OF CHRONIC ISCHEMIC STRUCTURAL HEART DISEASE WITH MODERATE-TO-SEVERE DEPRESSION OF LEFT VENTRICULAR SYSTOLIC FUNCTION, IN A PATIENT WITH A HISTORY OF PERCUTANEOUS REVASCULARIZATION OF THE RIGHT CORONARY ARTERY. APPROXIMATELY 15 MINUTES AFTER RF DELIVERY WAS PERFORMED AT THE ANTEROLATERAL LVOT BASE UNDER ICE GUIDANCE, AT A DISTANCE OF AT LEAST 2 CM FROM THE AORTIC ROOT AND WITH AN EXCLUSIVELY ENDOCARDIAL APPROACH, THE PATIENT DEVELOPED HYPOTENSION WITH GRADUAL HEMODYNAMIC DETERIORATION ASSOCIATED WITH ST-SEGMENT ELEVATION, FOLLOWED BY PEA WITH A TRANSIENT RESPONSE TO INOTROPIC SUPPORT. RESUSCITATION MANEUVERS WERE INITIATED WITH ESCALATION OF CATECHOLAMINE SUPPORT, FOLLOWED BY PLACEMENT OF VA-ECMO, AND CORONARY ANGIOGRAPHY WAS PERFORMED, REVEALING DIFFUSE CORONARY SPASM THAT PARTIALLY REGRESSED WITH NITRATES, IN THE ABSENCE OF HEMATOMA, DISS

  Patient problems: Arrhythmia; Cardiac Arrest; Vasoconstriction

  MAUDE report 24382378 ↗
• InjuryFeb 12, 2026Improper or Incorrect Procedure or Method; Air/Gas in Device

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, AIR EMBOLISM OCCURRED DURING THE SALINE SOLUTION EXCHANGE WHEN THE SALINE BAG FINISHED. THE AIR WAS INTRODUCED BECAUSE THE FLUSH OF THE NEW SALINE BAG WAS DONE WITH THE IRRIGATION CONNECTED TO THE PATIENT. THERE WERE TWO IRRIGATIONS, ONE FOR THE ADVISOR HD GRID CATHETER AND ONE FOR TACTIFLEX CATHETER. THE ADVISOR HD GRID STOPCOCK WAS CLOSED INSTEAD OF THE TACTIFLEX IRRIGATION. AT THE START, A 2:1 BLOCK OCCURRED, THAT BECAME A COMPLETE BLOCK, AND FINALLY FV. AN ECMO WAS USED TO MAINTAIN THE BLOOD CIRCULATION. MEDICATION WAS ADMINISTERED. THE PATIENT RECOVERED RHYTHM BUT A HEMORRHAGE WAS DETECTED AND THE PATIENT WAS SENT TO A CT SCAN. THE HEMORRHAGE WAS A BELLY HEMATOMA THAT OCCURRED FROM RESUSCITATION. THE CT SCAN COULD NOT FIND THE EXACT ORIGIN OF THE BELLY HEMATOMA. PATIENT IS RECOVERING IN THE ICU WITH VENTRICULAR DISFUNCTION AND AN EXTENSIVE HEMATOMA IN THE BELLY. THE PHYSICIAN ALLEGES THE ERROR IN THE INTERCHANGE OF THE SALINE BAG CONTRIBUTED TO THE AIR EMBOLUS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Air Embolism; Heart Block; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24324317 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PFA/RF PROCEDURE, A ROUTINE TRANSTHORACIC ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION ON THE CTI LINE IN THE RIGHT ATRIUM. NO INTERVENTION WAS NEEDED TO TREAT THE EFFUSION. THE PATIENT HAS EXPERIENCED NO SYMPTOMS DURING THE HOSPITAL STAY. IBUPROFEN WAS ADMINISTERED. PHYSICIAN STATES THAT NO PERFORATION OCCURRED AND ALLEGES THAT THE CAUSE FOR THE REPORTED MILD PERICARDIAL EFFUSION IS PROBABLY LONG RF ENERGY DELIVERY TO THE RIGHT ATRIAL ISTHMUS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Pericardial Effusion

  MAUDE report 24310516 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  AT THE END OF A VENTRICULAR TACHYCARDIA PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE PHYSICIAN THINKS THE PERFORATION COULD HAVE OCCURRED DURING A LARGE PATIENT MOVEMENT ON THE TABLE WITH THE CATHETER INSIDE OR POSSIBLY DURING CARDIOVERSION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24310501 ↗
• MalfunctionJan 3, 2026Communication or Transmission Problem

  DURING THE ATRIAL FLUTTER PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. AFTER ALL CONNECTIONS WERE ESTABLISHED, IT WAS NOTED THAT THE SIGNAL COULD NOT BE RECORDED, AND THE CATHETER WAS NOT DISPLAYED ON THE MONITORING SCREEN. THE CATHETER WAS EXCHANGED FOR A NEW ONE, BUT THE SAME ISSUE OCCURRED WITH THE REPLACEMENT CATHETER. THE SECOND CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952981 ↗
• MalfunctionJan 3, 2026Communication or Transmission Problem

  DURING THE ATRIAL FLUTTER PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. AFTER ALL CONNECTIONS WERE ESTABLISHED, IT WAS NOTED THAT THE SIGNAL COULD NOT BE RECORDED, AND THE CATHETER WAS NOT DISPLAYED ON THE MONITORING SCREEN. THE CATHETER WAS EXCHANGED FOR A NEW ONE, BUT THE SAME ISSUE OCCURRED WITH THE REPLACEMENT CATHETER. THE SECOND CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952971 ↗
• MalfunctionDec 31, 2025Signal Artifact/Noise; Signal Artifact/Noise

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935111 ↗
• MalfunctionDec 31, 2025Signal Artifact/Noise; Signal Artifact/Noise

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935109 ↗
• MalfunctionDec 18, 2025Fracture; Material Separation; Fracture; Material Separation

  THIS REPORT IS TO ADVISE OF A FRACTURED AND DETACHED TIP FOUND IN THE CATHETER DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837781 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE REDO PULMONARY VEIN ISOLATION PROCEDURE WITH RADIOFREQUENCY, AN EFFUSION WAS NOTED WITH ICE AND THE CHEST WAS OPENED FOR SURGERY. TRANSSEPTAL PUNCTURE WAS PERFORMED AND TOUCH UP ABLATION ON THE POSTERIOR WALL WAS PERFORMED. ALL CATHETERS WERE PULLED BACK TO THE RA AND A PARTIAL SVC ISOLATION WAS COMPLETED FOLLOWED BY A CTI. TOWARDS THE END OF ABLATION ON THE CTI LINE, AN EFFUSION WAS NOTED WITH ICE. CT SURGERY WAS CALLED AND THE CHEST WAS OPENED. CT SURGERY NOTED A PERFORATION AT THE IVC/RA JUNCTION WHICH WAS REPAIRED. THE PHYSICIAN ALLEGES THIS COULD HAVE BEEN CAUSED BY ABLATION. THE PATIENT WAS STABLE AND MOVED TO POST SURGICAL CARE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 23827970 ↗
• MalfunctionDec 16, 2025Optical Problem; Optical Problem

  DURING A TYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A CONTACT FORCE ISSUE RESULTING IN A DELAY. ONCE THE TACTIFLEX WAS INSERTED INTO THE PATIENT, THE DEVICE WAS VISIBLE ON ENSITE AND EGMS WERE PRESENT ON CLARIS; HOWEVER, THE CONTACT FORCE METRICS APPEARED IN PURPLE WITH NO INFORMATION. THE CABLE TO THE TACTISYS AND AMPLIFIER WERE RECONNECTED, BUT THE ISSUE REMAINED. THE TACTISYS UNIT WAS EXCHANGED, BUT THAT DID NOT RESOLVE THE ISSUE EITHER. FINALLY, 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 23824909 ↗
• MalfunctionDec 15, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, OUTPUT AND COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THE ABLATION CATHETER DID NOT HAVE CONTACT FORCE AND WAS SHOWING UP PURPLE DESPITE RESEEDING THE CATHETER, RECYCLING THE TACTISYS, AND RECYCLING THE AMPERE. THE CATHETER WAS EXCHANGED BUT THIS CATHETER HAD AN ISSUE WITH A MAGNETIC SENSOR AS IT WOULD NOT SHOW UP IN VOXEL MODE. THE SECOND CATHETER WAS REPLACED, AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE THIRD CATHETER AND WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812696 ↗
• MalfunctionDec 15, 2025Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, OUTPUT AND COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THE ABLATION CATHETER DID NOT HAVE CONTACT FORCE AND WAS SHOWING UP PURPLE DESPITE RESEEDING THE CATHETER, RECYCLING THE TACTISYS, AND RECYCLING THE AMPERE. THE CATHETER WAS EXCHANGED BUT THIS CATHETER HAD AN ISSUE WITH A MAGNETIC SENSOR AS IT WOULD NOT SHOW UP IN VOXEL MODE. THE SECOND CATHETER WAS REPLACED, AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE THIRD CATHETER AND WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812502 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED ON THE RV/RVOT FREE WALL RESULTING IN A PERICARDIOCENTESIS TO BE PERFORMED. DURING THE PROCEDURE, WHEN ABLATION FIRST CAME ON, CONTACT FORCE ON THE ABLATION CATHETER SHOWED 30G, AND THE GENERATOR METRICS SHOWED A CHANGE IN IMPEDANCE AND POWER DELIVERY. THE PATIENT REMAINED STABLE BUT DUE TO A SUSPICION OF A PERFORATION, FLUOROSCOPY AND INTRACARDIAC ECHO WERE PERFORMED WHICH CONFIRMED AN EFFUSION. BY THIS TIME THE PERFORATION HAD ALREADY SELF-CLOSED BUT A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE EFFUSION. THE PATIENT REMAINING STABLE THROUGHOUT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE, AND IT IS SUSPECTED THAT THE ANATOMICAL AREA WAS VERY THIN.

  Patient problems: Cardiac Perforation

  MAUDE report 23780750 ↗
• MalfunctionDec 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A DELAY DUE TO MAGNETIC SENSOR ISSUES. BOTH THE SE SENSOR OF THE DIAGNOSTIC CATHETER AND ABLATION CATHETER WERE NOT RECOGNIZED. THERE WAS NO ISSUE WITH THE CONNECTION. THE POTENTIALS DISPLAYED BUT THE SE INDICATOR REMAINED RED AND THE SENSOR WAS NOT RECOGNIZED. BOTH THE CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763869 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT SIDED PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, AN AORTIC DISSECTION OCCURRED. RETROGRADE ACCESS FROM THE RIGHT GROIN WAS OBTAINED WITH THE ULTIMUM 8F 12CM INTRODUCER WHICH WENT AS EXPECTED. THE LEFT SIDED PVC MAP WAS COMPLETED WITH AN HD GRID X SE MAPPING CATHETER WITH NO ISSUES. THE MAPPING CATHETER WAS REMOVED AND WHILE INSERTING THE TACTIFLEX SE ABLATION CATHETER, THE PHYSICIAN NOTED MINIMAL RESISTANCE IN THE GROIN, WHICH WAS DESCRIBED AS "KINKING" DUE TO ABNORMAL CURVATURE OF THE BLOOD VESSELS. THE PHYSICIAN MANEUVERED THE CATHETER IN THE GROIN REGION AND THE PATIENT COMPLAINED OF A HARD PAIN FROM THE RIGHT GROIN UP TO THE UPPER BACK AND IN THE CHEST REGION. THE CATHETER WAS REMOVED FROM THE PATIENT AND AN AORTOGRAM FOLLOWED BY A CT SCAN WERE DONE. MEDICATION THERAPY WAS ADMINISTERED TO TREAT THE DISSECTION, AND IT WAS MONITORED WITH REGULAR EXAMINATIONS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Great Vessel Perforation

  MAUDE report 23696780 ↗
• MalfunctionDec 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE TYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A DELAY DUE TO A CATHETER MAGNETIC SENSOR ISSUE. THE CATHETER WAS NOT COLLECTING SE DATA IN NAVX MODE AND COULD NOT BE VISUALIZED IN VOXEL MODE. THE TACTISYS WAS REPLACED WITH NO RESOLUTION. THEN A MAGNETIC SENSOR ERROR IN SE PORT 1 APPEARED. 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 23696249 ↗

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-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-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-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
• 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