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

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05415067034670), received between Jul 13, 2023 and Jan 28, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 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. 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-0113-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FLUTTER PROCEDURE, WHILE ABLATING THE CAVO-TRICUSPID ISTHMUS (CTI), A PRESSURE INDUCED PERFORATION OCCURRED WHICH REQUIRED SURGERY. THE PERFORATION WAS SUCCESSFULLY REPAIRED AND THE PATIENT STABILIZED. A BASAL POSTERIOR PERFORATION IN THE RIGHT VENTRICLE WAS CONFIRMED DURING SURGERY. THE PATIENT HAD A HYPER-MOBILE AND TORTUOUS CTI. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24198807 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  DURING A REDO ATRIAL FIBRILLATION PVI PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH DID NOT REQUIRE ANY INTERVENTION TO TREAT. THE ABLATION CATHETER WAS INSERTED INTO THE LEFT INFERIOR PULMONARY VEIN. HIGH FORCE WAS NOTED. A DROP IN BLOOD PRESSURE WAS OBSERVED, AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE PATIENT REMAINED STABLE, SO NO INTERVENTION WAS PERFORMED. THE PATIENT WILL BE MONITORED ON THE UNIT. THE PHYSICIAN BELIEVES THAT TOO MUCH FORCE WAS PUT ON THE CATHETER INTO THE TISSUE AS INDICATED BY THE HIGH CONTACT FORCE VALUE SEEN.

  Patient problems: Cardiac Perforation

  MAUDE report 24179068 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT ATRIAL FLUTTER PROCEDURE, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED SURGERY. A DROP IN BLOOD PRESSURE WAS OBSERVED. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED THE CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY SURGERY TO REPAIR A PERFORATION ON THE LEFT ATRIAL POSTERIOR WALL. NO HIGH CONTACT FORCE OR IMPEDANCE WAS NOTED. THE PHYSICIAN THINKS THE VERY THIN LEFT ATRIAL APPENDAGE WAS PERFORATED BY THE ABLATION CATHETER WHILE PACING WAS BEING PERFORMED AT THAT LOCATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23821109 ↗
• MalfunctionDec 12, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THERE WERE COMMUNICATION ISSUES WITH THE ADVISOR HD GRID X CATHETER AND THE TACTIFLEX ABLATION CATHETER RESULTING IN A DELAY. IT WAS NOTED THAT THE ADVISOR HD GRID X CATHETER COULD NOT BE VISUALIZED USING PORT 8 AND THAT A MAGNETIC SENSOR ERROR WAS DISPLAYED. THE CABLE WAS EXCHANGED, WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED, AND CONNECTED INTO PORT 7 WHICH RESOLVED THE ISSUE. HOWEVER, THE TACTIFLEX CATHETER ALSO WAS NOT BEING RECOGNIZED AND DISPLAYED AN ERROR STATING "CATHETER NOT CONNECTED". THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786717 ↗
• InjuryOct 28, 2025Optical Problem; Optical Problem

  AT THE END OF AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS AND PROTAMINE ADMINISTRATION TO STABILIZE THE PATIENT. PULMONARY VEIN ABLATION AND CTI WAS PERFORMED. A TRANSESOPHAGEAL ECHO WAS PERFORMED FOR TRANSSEPTAL PUNCTURE AND ABLATION OF 4 PULMONARY VEINS WAS PERFORMED. AT THE END, WHEN CHECKING ISOLATION OF THE VEINS WITH THE MAPPING CATHETER, THE CONTACT FORCE VALUE OF THE ABLATION CATHETER WAS NOT AVAILABLE. AN ERROR MESSAGE FROM THE TACTICS ON THE ENSITE X INDICATED « NO CONTACT FORCE SIGNAL OR OUT OF RANGE. CHECK CATHETER OPTICAL CONNECTION. CONTACT ABBOTT TECHNICAL SERVICE ». THE TACTISYS WAS TURNED OFF AND THE ABLATION CATHETER WAS DISCONNECTED. THE TACTISYS WAS THEN TURNED ON AND THE ABLATION CATHETER WAS RECONNECTED WHICH DID NOT RESOLVE THE ISSUE. THE CONTACT FORCE VALUE WAS INDICATED WHEN THE CATHETER WAS NOT DEFLECTED. ABLATION WAS DONE WITHOUT CONTACT FORCE IN THE RIGHT PULMONARY VEINS. AT THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS AND PROTAMINE WERE ADMINISTERED WHICH STABILIZED THE PATIENT. THE PATIENT LEFT THE OPERATING ROOM

  Patient problems: Cardiac Perforation

  MAUDE report 23402853 ↗
• MalfunctionOct 27, 2025Communication or Transmission Problem; Impedance Problem; Communication or Transmission Problem; Impedance Problem

  THE DEVICE WAS RECEIVED FOR EVALUATION. THIS REPORT INCLUDES AN UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393096 ↗
• MalfunctionJul 11, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A COMMUNICATION ISSUE OCCURRED RESULTING IN CANCELLATION OF THE PROCEDURE. THE CATHETER WAS INTERMITTENTLY SEEN ON THE ENSITE X IN VOXEL MODE AROUND THE LOW SEPTAL APEX AREA OF THE RIGHT VENTRICLE AND LEFT VENTRICLE. THERE WAS ALSO AN ICD LEAD IN THE SEPTAL AREA. PRS AND DISTORTION LEVELS WERE WITHIN RANGE AND THE CATHETER KEPT DISAPPEARING, EVEN DURING ABLATION. AFTER SOME ABLATIONS, THE CATHETER WAS STILL VISIBLE ON THE ENSITE X SYSTEM, BUT THE GENERATOR INDICATED A "CATHETER NOT CONNECTED" MESSAGE. SIGNALS WERE STILL ABLE TO BE SEEN, BUT ABLATION PARAMETERS WERE NOT FUNCTIONAL. THE PROCEDURE WAS THEN CANCELLED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478150 ↗
• InjuryNov 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE WAS FOUND REQUIRING A PERICARDIOCENTESIS. DURING THE PROCEDURE THERE WERE NO ISSUES OBSERVED, AND THE POST PROCEDURE ECHOCARDIOGRAM DID NOT SHOW ANY CONCERNS. HOWEVER, IN RECOVERY, THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED CHEST PAIN. AN ECHOCARDIOGRAM SHOWED THE CARDIAC TAMPONADE AND A PERICARDIOCENTESIS STABILIZED THE PATIENT. IT IS UNKNOWN WHEN THE PERFORATION OCCURRED.

  Patient problems: Cardiac Perforation

  MAUDE report 20703143 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERSISTENT ATRIAL FIBRILLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED REQUIRING A PERICARDIOCENTESIS. CIRCUMFERENTIAL ABLATION OF THE PULMONARY VEINS AND BLOCK LINES IN THE LEFT ATRIUM WERE PERFORMED. A BLOCK LINE WAS ALSO PERFORMED WITH THE SAME PARAMETERS ON THE CAVOTRICUSPID ISTHMUS. DURING THE FINAL APPLICATIONS, CLOSE TO THE INFERIOR VENA CAVA, THERE WAS DIFFICULTY IN CREATING SAFE LESIONS. IT WAS DECIDED TO PROCEED WITH HIGH-CONTACT AND FORCED POSITIONS, NOTICING IN SOME OF THEM A SENSATION OF PERFORATION. A CARDIAC PERFORATION WAS CONFIRMED THEN REQUIRING PERICARDIAL PUNCTURE, DRAINING APPROXIMATELY 100CC AND THE PATIENT STABILIZED. THE DRAIN WAS REMOVED THE NEXT DAY. THE CATHETER WAS DISCARDED.

  Patient problems: Cardiac Perforation

  MAUDE report 20519542 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. AFTER THE PROCEDURE, A TTE WAS PERFORMED WHICH SHOWED NO PERICARDIAL EFFUSION. LATER, A PERICARDIAL EFFUSION WAS NOTED BY MEDICAL STAFF. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 700CC WERE DRAINED FROM THE RIGHT SIDE AND THE PATIENT STABILIZED. NO INFUSION WAS NEEDED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 19975463 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A PREMATURE VENTRICULAR CONTRACTION PROCEDURE IN THE RIGHT VENTRICLE, A PERICARDIAL EFFUSION WAS NOTED ON AN ECHOCARDIOGRAM AT THE FRONT OF THE HEART BETWEEN THE AORTA AND THE LEFT CHAMBER. THERE WERE NO PATIENT SYMPTOMS OR SIGNS OF THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT IS UNKNOWN WHEN THE PERFORATION OCCURRED.

  Patient problems: Cardiac Perforation

  MAUDE report 19644070 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED. DURING THE PROCEDURE, BEFORE RF DELIVERY, AND AFTER CATHETERS ACCESS TO THE LEFT ATRIUM THROUGH PFO, THE PATIENT EXPERIENCED CHEST PAIN BUT NO PERICARDIAL EFFUSION WAS EVIDENT DURING THE ECHO AND THE PROCEDURE CONTINUED WITHOUT ISSUES DURING THE PULMONARY VEIN ISOLATION. APPROXIMATELY ONE HOUR FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 18343740 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING PERICARDIOCENTESIS. TRANSSEPTAL PUNCTURE WAS PERFORMED, A DECAPOLAR INQUIRY PROBE WAS PLACED IN THE CORONARY SINUS USING FLUOROSCOPY, AND THE LEFT ATRIUM WAS MAPPED USING AN ADVISOR FL SE 22MM MAPPING CATHETER. A TACTIFLEX SE ABLATION CATHETER WAS THEN INSERTED. THE SURGEON NOTED THAT HE WAS NOT CONFIDENT WITH THE ANATOMY, AS IT WAS A BIG ATRIUM, AND THERE WERE STRANGE FEELINGS MANIPULATING THE PROBES, SO IT WAS DECIDED TO PERFORM A TRANSTHORACIC ECHOCARDIOGRAM. A PERICARDIAL EFFUSION WAS FOUND. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. IT IS UNKNOWN WHAT CAUSED THE EFFUSION, BUT THE BLOOD APPEARED TO BE FROM THE RIGHT ATRIUM. THERE WERE NO PERFORMANCE ISSUES WITH ANY DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 18307451 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS HOSPITALIZED POST PROCEDURE DUE TO BREATHING ISSUES. AN ANGIO CT REVEALED A PULMONARY VEIN STENOSIS AND AN ANGIOPLASTY WAS DONE TO TREAT THE STENOSIS. THERE WAS NO ALLEGED MALFUNCTION WITH ANY ABBOTT DEVICE. DURING THE PULMONARY VEIN ISOLATION PROCEDURE ON (B)(6) 2023. ABLATION OF THE PULMONARY VEINS WAS COMPLETED IN A PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION WITH HIGH POWER AND SHORT DURATION STRATEGY. DURING THE PROCEDURE, ALL VEINS WERE TESTED IN ORDER TO VALIDATE ISOLATION. THE METHOD OF VALIDATION USED PACING INSIDE THE VEINS WITH AN HD GRID CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Stenosis

  MAUDE report 18129898 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY ONE MONTH FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE, PULMONARY VEINS STENOSIS WAS DIAGNOSED DURING A FOLLOWUP VISIT. DURING A PULMONARY VEIN ISOLATION PROCEDURE IN A PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION, ABLATION OF THE PULMONARY VEINS WAS COMPLETED WITH THE ABLATION CATHETER, WITH HIGH POWER SHORT DURATION STRATEGY. DURING THE PROCEDURE, ALL VEINS WERE TESTED IN ORDER TO VALIDATE ISOLATION. METHOD OF VALIDATION USED PACING INSIDE THE VEINS USING THE HD GRID CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. APPROXIMATELY ONE MONTH POST PROCEDURE, PULMONARY VEINS STENOSIS WAS DIAGNOSED.

  Patient problems: Stenosis

  MAUDE report 17767664 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST ABLATION PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT WITH THERAPY PLANNED. THE PATIENT PRESENTED TO THE HOSPITAL WITH MILD WEAKNESS OF THE LEFT LABIAL ANGLE AND SLIGHT SALIVARY FLOW. THE PATIENT REPORTED THAT THE SYMPTOMS HAD OCCURRED FOLLOWING THEIR ABLATION PROCEDURE ON (B)(6) 2023. AN MRI SHOWED A 13X7 MM ISCHEMIC LESION IN THE RIGHT CENTRUM SEMIOVALE. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 AND REFERRED FOR OUTPATIENT NEUROLOGICAL THERAPY PLANNING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES USED.

  Patient problems: Stroke/CVA

  MAUDE report 17767208 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY ONE MONTH FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE, PULMONARY VEINS STENOSIS WAS DIAGNOSED DURING A FOLLOWUP VISIT. DURING A PULMONARY VEIN ISOLATION PROCEDURE IN A PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION, ABLATION OF THE PULMONARY VEINS WAS COMPLETED WITH THE ABLATION CATHETER, WITH HIGH POWER SHORT DURATION STRATEGY. DURING THE PROCEDURE, ALL VEINS WERE TESTED IN ORDER TO VALIDATE ISOLATION. METHOD OF VALIDATION USED PACING INSIDE THE VEINS USING THE HD GRID CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. APPROXIMATELY ONE MONTH POST PROCEDURE, PULMONARY VEINS STENOSIS WAS DIAGNOSED.

  Patient problems: Stenosis

  MAUDE report 17743851 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED IN THE LEFT PULMONARY VEIN REQUIRING A PERICARDIOCENTESIS. FOLLOWING PULMONARY VEIN ISOLATION, THE PATIENT BECAME HYPOTENSIVE AND ECHOCARDIOGRAM REVEALED AN EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 17317495 ↗

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-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-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-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