TactiCathRecalls & reported problems across all models

We found 10 models of TactiCath by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,978 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 29, 2026 — classified as 42 deaths, 825 injuries, 1,111 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (310 reports).

3 FDA recall records name at least one of these models by its device identifier.

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

TactiCath 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. Jun 9, 2022Terminated

   When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."

   Z-1344-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 24, 2022Terminated

   Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

   Z-0957-2022 · Root cause: Process control · Recall details · FDA record ↗

3. Mar 24, 2022Terminated

   Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

   Z-0956-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported TactiCath problems

TactiCath models

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

• TactiCath™ A-TCSE-DF

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall23 deaths923 reports
• TactiCath™ PN-004075

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  7 deaths338 reports
• TactiCath™ A-TCSE-FJ

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall3 deaths174 reports
• TactiCath™ A-TCSE-D

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 deaths175 reports
• TactiCath™ A-TCSE-DD

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall104 reports
• TactiCath™ Quartz 65

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 deaths131 reports
• TactiCath™ A-TCSE-F

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  5 deaths122 reports
• TactiCath™ A-TCSE-J

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  8 reports
• TactiCath™ A-TCSE-FF

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 reports
• TactiCath™ A-TCSE-JJ

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

Recent TactiCath 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 an atrial fibrillation procedure with a TactiCath SE catheter and non-Abbott (Boston Scientific SureFlex) sheath, the patient experienced a drop in blood pressure from 122/74 to 73/55 mmHg. The procedure was stopped and a routine postoperative ultrasound was performed. A pericardial effusion was detected, and the condition was diagnosed as an acute tamponade. It was noted that the procedure was difficult from the start due to atypical patient anatomy of the venous course and a "strange cardiac axis". After the left atrium was mapped, it was determined an additional LSPV had not yet been treated. During ablation, there were several instances of contact pressure spikes or around 160 g on the TactiCath catheter. The physician attributed this to the "poor quality" of the non-Abbot (Boston Scientific SureFlex) sheath and patient anatomy. Approximately 6 minutes later the patient experienced the drop in blood pressure. The patient was discharged after 2 nights of monitoring. The physician stated there were no performance issues with any Abbott devices.

  Patient problems: Cardiac Perforation

  MAUDE report 50937931 ↗
• MalfunctionSep 24, 2026Fracture; Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886247 ↗
• MalfunctionAug 19, 2026Optical Problem

  During a Paroxysmal Atrial Fibrillation procedure, a delay of approximately 1 hour occurred when pressure readings were not displayed on the system. The TactiCath Catheter was exchanged; however, the issue persisted. Multiple system and equipment restarts were subsequently performed. Following an additional restart, pressure readings became available for both TactiCath Catheters, but the initial catheter continued to demonstrate intermittent pressure display readings. The procedure was completed without adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323360 ↗
• MalfunctionAug 19, 2026Optical Problem

  During a Paroxysmal Atrial Fibrillation procedure, a delay of approximately 1 hour occurred when pressure readings were not displayed on the system. The TactiCath Catheter was exchanged; however, the issue persisted. Multiple system and equipment restarts were subsequently performed. Following an additional restart, pressure readings became available for both TactiCath Catheters, but the initial catheter continued to demonstrate intermittent pressure display readings. The procedure was completed without adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323355 ↗
• MalfunctionApr 7, 2026Use of Device Problem; Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF AN EXPIRED CATHETER USED DURING THE PROCEDURE. DURING THE AF PROCEDURE, AN EXPIRED CATHETER WAS USED. THE CATHETER WAS NOT VISUALIZED AND THE LSI PARAMETERS WERE NOT DISPLAYED. ALTHOUGH THE CATHETER ITSELF APPEARED ON THE SCREEN, THE WINDOW DISPLAYING THE CATHETER-RELATED CONTACT FORCE AND LSI PARAMETERS APPEARED BUT DID NOT SHOW ANY DATA. THE METAL BASELINE WAS SET, AS WAS THE DISTORTION. THE SIGNALS FROM THE CATHETER ELECTRODES DID NOT APPEAR ON EITHER THE ENSITE SYSTEM OR THE NON-ABBOTT (PRUCKA) EP SYSTEM. AS A PRECAUTION, THE CONNECTIONS BETWEEN THE TACTISYS AND THE TACTICATH CATHETER WERE CHECKED; HOWEVER, THE ISSUE COULD NOT BE IDENTIFIED. THE CONNECTION BETWEEN THE TACTISYS SYSTEM AND THE GENERATOR WAS ALSO CHECKED, ALONG WITH ALL AMPLIFIER CONNECTIONS. THE CATHETER WAS USED AS DESCRIBED IN THE IFU. ULTIMATELY, THE ISSUE WAS RESOLVED BY USING A NEWLY OPENED TACTIFLEX CATHETER, WHICH IMMEDIATELY DISPLAYED VALUES ON THE ICON AFTER INSERTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803596 ↗
• DeathMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AF) PROCEDURE ON (B)(6) 2026. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL ON (B)(6) 2026 WITH CHEST PAIN, FEVER, AND SKIN MOTTLING. THE PATIENT DISPLAYED AN ALTERED CONSCIOUSNESS STATE WITH GLASGOW SCORE OF 11. A CT SCAN SHOWED MEDIASTINAL AIR BUBBLES AND INTRA CARDIAC AIR BUBBLES WHICH LEAD TO AN ATRIOESOPHAGEAL FISTULA. THE FISTULA WAS LOCATED POSTERIOR TO THE LEFT SUPERIOR PULMONARY VEIN OSTIUM. CARDIAC SURGERY WAS PERFORMED WHERE A PATCH WAS PLACED. THE PATIENT DIED ON (B)(6) 2026. A NON-ABBOTT TEMPERATURE PROBE (PROACT REF. (B)(4)) HAD BEEN USED DURING THE AF PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE FISTULA. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Perforation of Esophagus

  MAUDE report 24743950 ↗
• MalfunctionMar 13, 2026Optical Problem

  DURING AN AVRT PROCEDURE, DIFFICULTY WAS NOTED DURING TRANSSEPTAL PUNCTURE. THE NEEDLE FAILED TO PASS THROUGH THE SL1 SHEATH DESPITE MULTIPLE ATTEMPTS. THE NEEDLE WAS REPLACED AND THE TRANSSEPTAL PUNCTURE WAS PERFORMED. DURING ABLATION IT WAS NOTED THAT THE CATHETER HAD PRESSURE MALFUNCTION AND COULD NOT ACCURATELY DISPLAY PRESSURE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589715 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE LEFT SIDED ATYPICAL ATRIAL FLUTTER PROCEDURE, A CARDIAC PERFORATION OCCURRED WHICH RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED. WHILE THE PHYSICIAN WAS ABLATING A ROOF LINE, HYPOTENSION OCCURRED AND A PERICARDIAL EFFUSION WAS CONFIRMED WITH ICE. TREATMENT WAS PERFORMED FOR THE EFFUSION WHICH CONSISTED OF PUNCTURING THE PERICARDIAL, REMOVING BLOOD, AND REINJECTING IT INTO THE ATRIAL ACCESS. 2500IE PBSP, 28000IE PROTAMIN, AND 2G TRANEXAMIC ACID WERE ADMINISTERED OVER THE COURSE OF THE PUNCTURE AND 2 VIALS CALCIUM CARBONATE. THE EFFUSION WAS STOPPED. THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 24563537 ↗
• MalfunctionMar 10, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS. DURING AN ATRIAL FIBRILLATION (APOPLEXY) PROCEDURE, THE CATHETER SHOWED NO PRESSURE. A NEW CATHETER WAS USED TO CONTINUE THE PROCEDURE, WHICH WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561503 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  AN BAIFU, ZHANG XUELIAN, BAI MEI, ET AL. EFFECT OF USING IMPEDANCE CHANGE MONITORING TO ASSIST LESION INDEX¿GUIDED HIGH-POWER ABLATION FOR ATRIAL FIBRILLATION. CHINESE JOURNAL OF GERIATRICS, 2025, 45(08): 1793¿1796. A TOTAL OF 50 PATIENTS WHO UNDERWENT HIGH-POWER (40¿45 W) ATRIAL FIBRILLATION ABLATION GUIDED BY THE LESION SIZE INDEX (LSI) WERE ENROLLED AS THE CONTROL GROUP. ANOTHER 50 NEWLY SELECTED PATIENTS WHO MET THE INDICATIONS FOR RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION WERE INCLUDED AS THE STUDY GROUP. ABLATION IN THE STUDY GROUP WAS INITIATED USING THE SAME HIGH-POWER SETTINGS AS THE CONTROL GROUP. DURING THE PROCEDURE, THE BASELINE IMPEDANCE AND IMPEDANCE DROP AT EACH ABLATION POINT WERE MONITORED. WHEN THE LSI REACHED THE TARGET VALUE BUT THE IMPEDANCE DROP WAS <10%, THE ABLATION PARAMETERS AND THE CONTACT FORCE OF THE ABLATION CATHETER WERE ADJUSTED, FOLLOWED BY ADDITIONAL ABLATION. IF AN IMPEDANCE RISE OCCURRED DURING ABLATION OR IF THE IMPEDANCE DROPPED BY >15% WITHIN THE FIRST 5 SECONDS, THE ABLATION WAS IMMEDIATELY TERMINATED. 4 STEAM POPS AND 1 STEAM POP FOLLOWED BY A PERICARDIAL EFFUSION REQUIRING A PERICARDIOCENTESIS WERE REPORTED.

  Patient problems: Cardiac Perforation

  MAUDE report 24547008 ↗
• MalfunctionMar 8, 2026Communication or Transmission Problem

  DURING THE PVC PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THERE WAS AN ERROR MESSAGE THAT WAS DISPLAYED INDICATING THE CATHETER DATA WAS INVALID AND THE CATHETER COULD NOT BE DISPLAYED. THE MESSAGE ALSO INDICATED THAT THE CATHETER WAS BEING USED BY A DIFFERENT PATIENT. THE CONNECTIONS WERE CHECKED, AND ANOTHER CATHETER WAS TRIED. THE ENTIRE SYSTEM, INCLUDING THE ENSITE X AMPLIFIER, MAIN UNIT, AND LIGHT SOURCE WERE RESTARTED, BUT THE ISSUE WAS NOT RESOLVED. THE 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 24542186 ↗
• MalfunctionMar 8, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS. DURING ATRIAL FIBRILLATION SURGERY, AFTER CORRECTLY REMOVING THE CATHETER AND CONNECTING THE PRESSURE MODULE, THE PRESSURE WAS NOT DISPLAYED. RE-INSERTING THE TAIL WIRE DID NOT SOLVE THE PROBLEM. AFTER REPLACING THE CATHETER, THE PROBLEM WAS RESOLVED, AND THE SURGERY WAS COMPLETED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542130 ↗
• MalfunctionMar 4, 2026Communication or Transmission Problem

  DURING THE PVC PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE ABLATION CATHETER WAS NOT LOCATING ON THE ENSITE MAPPING SYSTEM UPON CONNECTION. ENSITE PROMPTED THAT THE CATHETER HAD A SENSOR ISSUE IN THE PORT. THE TACTISYS WAS REPLACED, THE SE EXTENSION WAS BYPASSED, AND THE CATHETER WAS DIRECTLY PLUGGED INTO ENSITE MAPPING AMPLIFIER, 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 24510300 ↗
• MalfunctionFeb 26, 2026Optical Problem

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP WITH PROTRUDING COMPONENTS DURING INVESTIGATION. DURING THE SVT PROCEDURE, IT WAS NOTED THAT THE CONTACT FORCE WAS NOT DISPLAYED ACCURATELY. THE CONTACT FORCE WAS RESET; HOWEVER, THE ISSUE PERSISTED. THE ENSITE SYSTEM DISPLAYED AN ERROR MESSAGE STATING THAT NO CONTACT FORCE WAS AVAILABLE. THE CONNECTIONS WERE CHECKED AND THE TACTISYS WAS RESTARTED WITH NO RESOLUTION. THE 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 24457873 ↗
• MalfunctionFeb 26, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE WITH A PROTRUDING WIRE FOUND IN THE CATHETER SHAFT DURING ANALYSIS. DURING THE AFL PROCEDURE, AFTER ABLATION FOR A PERIOD OF TIME THROUGH THE ADJUSTABLE CURVED SHEATH, THE CATHETER COULD NO LONGER BEND TO THE OTHER SIDE. AFTER REPLACING THE CATHETER, THE PROCEDURE PROCEEDED SMOOTHLY WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457640 ↗

Other St. Jude Medical, Inc. products

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