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

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05415067034557), received between Sep 8, 2023 and Nov 3, 2025 — classified as 6 injuries, 8 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. 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-0110-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE TACTIFLEX CATHETER RESULTING IN A DELAY. WHEN THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE TACISYS AND ENSITE, THE SE INDICATOR REMAINED RED AND THE NAVIGATION WAS NOT DISPLAYED. NO ERROR MESSAGE WAS DISPLAYED. THE CATHETER WAS RECONNECTED TO THE ENSITE AND THE ENSITE WAS RESTARTED, BUT THE SE FUNCTION WAS NOT RECOGNIZED. 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 23458059 ↗
• MalfunctionJan 3, 2025Optical Problem; Optical Problem

  DURING PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS NO CONTACT FORCE RESULTING IN A DELAY. WHEN THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE TACTISYS AND ENSITE SYSTEM, CONTACT FORCE WAS DISPLAYED IN PURPLE FONT AS "--G". THE CATHETER AND TACTISYS WERE RECONNECTED, AND THE DISPLAY WORKSTATION WAS RESTARTED, BUT THE CONTACT FORCE VALUE WAS NOT DISPLAYED. THE CATHETER WAS REPLACED, WHICH RESOLVE THE ISSUE, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21070993 ↗
• InjuryDec 10, 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 TO STABILIZE THE PATIENT. TRANSSEPTAL PUNCTURE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY, AND THE TACTIFLEX SE DD, HD GRID, AND OPTIMA CATHETERS WERE INSERTED INTO THE LEFT ATRIUM. AFTER MAPPING, ABLATION WAS STARTED FROM THE LEFT PULMONARY VEIN (LPV). IN THE MIDDLE OF THE ABLATION AT THE LPV, THE PATIENTS BLOOD PRESSURE DECREASED. WHEN FLUOROSCOPY AND ECHOGRAPHY WERE CHECKED, A CARDIAC TAMPONADE WAS NOTED AND DRAINAGE WAS STARTED. AFTER THAT, MEDICINE WAS ADMINISTERED, AND THE DRAINAGE WAS CONTINUED. THE BLEEDING DECREASED, BLOOD PRESSURE INCREASED TO A NORMAL LEVEL AND THE BLEEDING STOPPED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20891925 ↗
• InjurySep 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A STEAM POP AND CARDIAC PERFORATION OCCURRED REQUIRING A PERICARDIOCENTESIS. IT WAS NOTED THAT A POP OCCURRED IN THE RIGHT ATRIAL ANTERIOR. ELECTRICAL CONDUCTION WAS INITIATED FROM THE POSTERIOR SIDE OF THE RIGHT PULMONARY VEIN ROOF, AND A POP OCCURRED WHEN PASSING THE BOTTOM AND REACHED THE ANTERIOR SIDE. AFTER THE POP WAS CONFIRMED, A PERICARDIOCENTESIS WAS PERFORMED FOR TREATMENT. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 20333122 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE LEFT PULMONARY VEIN ISOLATION WAS COMPLETED, AND WHEN MOVING TO THE RIGHT PULMONARY VEIN, THE PATIENT BECAME HYPOTENSIVE. AN ECHOGRAPHY REVEALED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 20272318 ↗
• MalfunctionAug 6, 2024Overheating of Device; Overheating of Device

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WAS A TEMPERATURE ISSUE RESULTING IN CANCELLATION OF THE PROCEDURE. WHILE ABLATING IN THE RVOT 2, THE EARLIEST ACTIVATION AT INFUNDIBULUM, THE TEMPERATURE ALARM SOUNDED. THE TIP ORIENTATION DURING ABLATION WAS AT A SLIGHT ANGLE, BUT RATHER PERPENDICULAR. WHEN A SECOND ABLATION WAS PERFORMED, THE FOLLOWING ERROR MESSAGE WAS DISPLAYED ON THE AMPERE: "POWER NOT POSSIBLE". TROUBLESHOOTING WAS DONE BY RESTARTING AND RECONNECTING THE CATHETER AND THE FIRST ATTEMPTED ABLATION ERROR WAS AS FOLLOWING: "MEASURED POWER HIGHER THAN PROGRAMMED VALUE". THE DECISION WAS MADE TO END THE PROCEDURE AND NOT EXCHANGE THE CATHETER DUE TO TIME CONSTRAINTS AND THE NEED TO REINDUCE THE PVCS. THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925333 ↗
• MalfunctionApr 2, 2024Overheating of Device; Overheating of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A TEMPERATURE PROBLEM OCCURRED WHICH CAUSED A DELAY. DURING AN ATRIAL FIBRILLATION PROCEDURE FOR ATRIAL FLUTTER (AFL), RF DELIVERY WAS PERFORMED AT THE CTI FIRST. THE TEMPERATURE SETTING WAS 35W AND TEMPERATURE CONTROL WAS ACTIVATED OCCASIONALLY, BUT THE OUTPUT POWER INCREASED. DUE TO THE ANATOMY OF THE POUCH, TEMPERATURE CONTROL WAS ACTIVATED AND THE PROCEDURE CONTINUED. HOWEVER, THE AFL DID NOT STOP, AND RF DELIVERY WAS PERFORMED SUCCESSFULLY TO STOP THE AFL. WHEN APPROACHING THE LEFT ATRIUM AND STARTING RF DELIVERY AT THE PULMONARY VEIN RECONDUCTION SITE (AT 50W), THE OUTPUT DID NOT INCREASE; THE TEMPERATURE AND OUTPUT FLUCTUATED ON THE GENERATOR WAVEFORMS OF THE ENSITE. THE CATHETER WAS THEN REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A PROCEDURE DELAY OF APPROXIMATELY 3 TO 4 HOURS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018485 ↗
• InjuryMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CTI ABLATION, A STEAM POP FOLLOWED BY A PERFORATION OCCURRED WITH NO TREATMENT NEEDED. THE SETTINGS WERE 35 W AND 45 DEGREES, AUTOFLOW WAS 13 ML/MIN AND A POP OCCURRED. THE PATIENT BECAME HYPOTENSIVE AND MILD CARDIAC FLUID RETENTION WAS CONFIRMED. NO TREATMENT WAS NEEDED AND THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 18827144 ↗
• MalfunctionJan 11, 2024Failure to Deliver Energy; Failure to Deliver Energy

  RELATED MANUFACTURING REF: 3005334138-2024-00009, 3005334138-2024-00011 DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN THE TACTIFLEX ABLATION CATHETER (LOT: 9066884) WAS CONNECTED, THE ELECTRIC POTENTIALS WERE DISPLAYED PROPERLY, BUT THE SENSORS WAS NOT RECOGNIZED AT ALL. THE TACTIFLEX ABLATION CATHETER WAS RECONNECTED THREE TIMES, AND THE CATHETER PRESETS WERE RELOADED, AND RECREATED FROM THE NOMINAL, BUT WITH NO RESOLUTION. THE ENSITE X SYSTEM WAS RESTARTED TWO TIMES, THE AMPLIFIER AND THE DISPLAY WORKSTATION WERE ALSO RESTARTED AT THE SAME TIME, BUT WITH NO RESOLUTION. WHEN THE TACTIFLEX ABLATION CATHETER (LOT: 9066884) WAS REPLACED WITH A 2ND IT (LOT: 9096966), THE SE ISSUE WAS RESOLVED. THE SECOND TACTIFLEX ABLATION CATHETER(LOT: 9096966) WAS WORKING PROPERLY AT FIRST. HOWEVER, APPROXIMATELY 20 MINUTES LATER, THE OUTPUT CONTROL WAS ACTIVATED EVEN THOUGH THE TEMPERATURE WAS LOWER, AROUND 38 DEGREES C, THAN THE SETTING VALUE OF TEMPGUARD, 42 DGREES C. THE OUTPUT ONLY INCREASED TO 30 WATTS RATHER THAN THE SET VALUE, 50 WATTS. WHEN THE 2ND TACTIFLEX ABLATION CATHETER (LOT: 9096966) WAS REPLACED WITH A 3RD IT (LOT: 9096966), THE OUTPUT ISSUE WAS RESOLVED. THE THIRD TACTIFLEX ABLATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490465 ↗
• MalfunctionJan 11, 2024Overheating of Device; Overheating of Device

  RELATED MANUFACTURING REF: 3005334138-2024-00009, 3005334138-2024-00010. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN THE TACTIFLEX ABLATION CATHETER (LOT: 9066884) WAS CONNECTED, THE ELECTRIC POTENTIALS WERE DISPLAYED PROPERLY, BUT THE SENSORS WAS NOT RECOGNIZED AT ALL. THE TACTIFLEX ABLATION CATHETER WAS RECONNECTED THREE TIMES, AND THE CATHETER PRESETS WERE RELOADED, AND RECREATED FROM THE NOMINAL, BUT WITH NO RESOLUTION. THE ENSITE X SYSTEM WAS RESTARTED TWO TIMES, THE AMPLIFIER AND THE DISPLAY WORKSTATION WERE ALSO RESTARTED AT THE SAME TIME, BUT WITH NO RESOLUTION. WHEN THE TACTIFLEX ABLATION CATHETER (LOT: 9066884) WAS REPLACED WITH A 2ND IT (LOT: 9096966), THE SE ISSUE WAS RESOLVED. THE SECOND TACTIFLEX ABLATION CATHETER(LOT: 9096966) WAS WORKING PROPERLY AT FIRST. HOWEVER, APPROXIMATELY 20 MINUTES LATER, THE OUTPUT CONTROL WAS ACTIVATED EVEN THOUGH THE TEMPERATURE WAS LOWER, AROUND 38 DEGREES C, THAN THE SETTING VALUE OF TEMPGUARD, 42 DGREES C. THE OUTPUT ONLY INCREASED TO 30 WATTS RATHER THAN THE SET VALUE, 50 WATTS. WHEN THE 2ND TACTIFLEX ABLATION CATHETER (LOT: 9096966) WAS REPLACED WITH A 3RD IT (LOT: 9096966), THE OUTPUT ISSUE WAS RESOLVED. THE THIRD TACTIFLEX ABLATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490435 ↗
• MalfunctionJan 11, 2024Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 3005334138-2024-00010, 3005334138-2024-00011. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN THE TACTIFLEX ABLATION CATHETER (LOT: 9066884) WAS CONNECTED, THE ELECTRIC POTENTIALS WERE DISPLAYED PROPERLY, BUT THE SENSORS WAS NOT RECOGNIZED AT ALL. THE TACTIFLEX ABLATION CATHETER WAS RECONNECTED THREE TIMES, AND THE CATHETER PRESETS WERE RELOADED, AND RECREATED FROM THE NOMINAL, BUT WITH NO RESOLUTION. THE ENSITE X SYSTEM WAS RESTARTED TWO TIMES, THE AMPLIFIER AND THE DISPLAY WORKSTATION WERE ALSO RESTARTED AT THE SAME TIME, BUT WITH NO RESOLUTION. WHEN THE TACTIFLEX ABLATION CATHETER (LOT: 9066884) WAS REPLACED WITH A 2ND IT (LOT: 9096966), THE SE ISSUE WAS RESOLVED. THE SECOND TACTIFLEX ABLATION CATHETER(LOT: 9096966) WAS WORKING PROPERLY AT FIRST. HOWEVER, APPROXIMATELY 20 MINUTES LATER, THE OUTPUT CONTROL WAS ACTIVATED EVEN THOUGH THE TEMPERATURE WAS LOWER, AROUND 38 DEGREES C, THAN THE SETTING VALUE OF TEMPGUARD, 42 DGREES C. THE OUTPUT ONLY INCREASED TO 30 WATTS RATHER THAN THE SET VALUE, 50 WATTS. WHEN THE 2ND TACTIFLEX ABLATION CATHETER (LOT: 9096966) WAS REPLACED WITH A 3RD IT (LOT: 9096966), THE OUTPUT ISSUE WAS RESOLVED. THE THIRD TACTIFLEX ABLATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490428 ↗
• InjuryNov 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A STEAM POP AND CARDIAC TAMPONADE OCCURRED WHICH REQUIRED A THORACOTOMY TO STABILIZE THE PATIENT. FOLLOWING PULMONARY VEIN (PV) ISOLATION, SLOW PATHWAY ABLATION WAS PERFORMED DUE TO THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA. AFTER PROGRAMMED ELECTRICAL STIMULATION WAS PERFORMED, AN ATRIAL FLUTTER OCCURRED. THEREFORE, CTI WAS PERFORMED AND A STEAM POP OCCURRED NEAR THE INFERIOR VENA CAVE (POWER 38W, TEMPERATURE 43). WHILE CHECKING FOR THE PV, THE PATIENT'S CONDITION DETERIORATED AND PROGRESSED FROM ST ELEVATION TO VENTRICULAR TACHYCARDIA. AN ECHOGRAPHY REVEALED A CARDIAC TAMPONADE WHICH REQUIRED A THORACOTOMY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 18194255 ↗
• MalfunctionOct 20, 2023Fracture; Communication or Transmission Problem; Electrical Shorting; Fracture; Communication or Transmission Problem; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977201 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A CARDIAC PERFORATION WAS NOTED IN THE LEFT ATRIAL APPENDAGE WHICH REQUIRED A PERICARDIOCENTESIS. THE CATHETER WAS INSERTED INTO LEFTEE SHEATH (JLL) AND THE DEVICES WERE INSERTED INTO THE LEFT ATRIUM. DURING MANIPULATION OF THE SHEATH, THE LEFT ATRIAL APPENDAGE MAY HAVE BEEN POKED WITH THE CATHETER WITHOUT NOTICING THAT THE TIP OF THE CATHETER WAS PROTRUDING FROM THE TIP OF THE SHEATH. A FEW RF DELIVERIES WERE APPLIED AROUND THE LEFT ATRIAL APPENDAGE, AND THE ANTERIOR BLOCK AND THE LEFT ATRIAL ABLATION HAD BEEN COMPLETED. THE PATIENT THEN BECAME HYPOTENSIVE AND WAS IN STATE OF SHOCK. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER, A BLOOD TRANSFUSION WAS PERFORMED, AND HEMODYNAMICS WERE MAINTAINED. EMERGENCY SURGERY WAS PERFORMED, AND THE PATIENT IS STABLE. THE ABLATION PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ABLATION CATHETER. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 17714130 ↗

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-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-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-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