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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067034656), received between Sep 11, 2024 and Mar 10, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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-0109-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• 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 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 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL TAMPONADE OCCURRED, RESULTING IN A PERICARDIOCENTESIS AND THE PATIENT GOING TO THE OPERATING ROOM. THE PROCEDURE WAS COMPLETED WITH NO ISSUES, INCLUDING AN ULTRASOUND BEING PERFORMED THAT SHOWED NO EVIDENCE OF A PERICARDIAL EFFUSION. THE PATIENT WAS STABLE AND TAKEN TO THE HOSPITAL WARD. A COUPLE OF HOURS AFTER THE PROCEDURE THE PATIENT BEGAN TO NOT FEEL WELL SO ANOTHER ULTRASOUND WAS PERFORMED WHICH REVEALED THE PERICARDIAL TAMPONADE. THE PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB WHERE APPROXIMATELY 300ML OF BLOOD WAS DRAINED. A PERFORATION COULD NOT BE LOCATED PRECISELY, SO THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM BUT REMAINED STABLE, SO NO FURTHER INTERVENTION WAS REQUIRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING PROCEDURE. THE PHYSICIAN STATED THAT THE EFFUSION WAS MOST LIKELY A RESULT OF THE ABLATION BEING PERFORMED.

  Patient problems: Cardiac Perforation

  MAUDE report 23813082 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION, THE PATIENT SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. DURING ABLATION, THE PATIENT REPORTED PAIN AND A DROP IN BLOOD PRESSURE WAS OBSERVED. AN ULTRASOUND WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. THE PERFORATION WAS LOCATED IN THE CS. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23476051 ↗
• MalfunctionNov 3, 2025Overheating of Device; Overheating of Device

  THIS REPORT INCLUDES AN UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450835 ↗
• MalfunctionSep 4, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. AFTER INSERTING THE CATHETER INTO THE PATIENT, NOISE WAS OBSERVED ON WAVEFORMS 1 AND 2. DEVICE CONNECTIONS WERE CHECKED, AND THE SYSTEM WAS RESTARTED, BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED, AND THE NOISE WAS SLIGHTLY REDUCED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974507 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A CARDIAC TAMPONADE WAS NOTED FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. ABLATION OF THE LEFT-LATERAL (LL) ACCESSORY PATHWAY WAS PERFORMED WITH RETRO-AORTIC APPROACH WITH HIGH CONTACT FORCE. THE REP TOLD THE PHYSICIAN HE WAS USING A LOG OF FORCE. IRRIGATION WAS PERFORMED WITH 20-25 G MAX (JUST ONE REACHED 40 G FOR JUST FEW SECONDS). THE PATIENT BECAME HYPOTENSIVE, AND AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 22319877 ↗
• MalfunctionMay 6, 2025Use of Device Problem; Use of Device Problem

  THIS REPORT IS TO ADVISE THAT AN EXPIRED DEVICE WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967229 ↗
• MalfunctionSep 11, 2024Optical Problem; Optical Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2024-00372. DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, OPTICAL ISSUES WITH THE CATHETER RESULTED IN A PROCEDURAL DELAY. WHILE AT THE VASCULAR ACCESS STEP, IT WAS NOTED THAT THE ABLATION CATHETER WOULD NOT DISPLAY PRESSURE INFORMATION ON THE ENSITE X DWS, AN ERROR MESSAGE SHOWED, -- G CONTACT FORCE DATA IN PURPLE WAS DISPLAYED. THE CATHETER WAS RECONNECTED MULTIPLE TIMES, THE TACTISYS WAS RESTARTED, THE CATHETER PRESET WAS RELOADED AND THE STUDY WAS RESTARTED, ALL WITH NO RESOLUTION. THE SAME ISSUE OCCURRED WITH THE SECOND CATHETER. THE CATHETER WAS EXCHANGED FOR A THIRD WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190290 ↗
• MalfunctionSep 11, 2024Optical Problem; Optical Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2024-00373. DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, OPTICAL ISSUES WITH THE CATHETER RESULTED IN A PROCEDURAL DELAY. WHILE AT THE VASCULAR ACCESS STEP, IT WAS NOTED THAT THE ABLATION CATHETER WOULD NOT DISPLAY PRESSURE INFORMATION ON THE ENSITE X DWS, AN ERROR MESSAGE SHOWED, -- G CONTACT FORCE DATA IN PURPLE WAS DISPLAYED. THE CATHETER WAS RECONNECTED MULTIPLE TIMES, THE TACTISYS WAS RESTARTED, THE CATHETER PRESET WAS RELOADED AND THE STUDY WAS RESTARTED, ALL WITH NO RESOLUTION. THE SAME ISSUE OCCURRED WITH THE SECOND CATHETER. THE CATHETER WAS EXCHANGED FOR A THIRD WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190182 ↗

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-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-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