TactiCath™ A-TCSE-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 05415067027689), received between Jun 13, 2018 and Sep 29, 2026 — classified as 2 deaths, 62 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Fracture” (70 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 175 reports, 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 ↗
• 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 ↗
• MalfunctionDec 5, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP WITH A PROTRUDING COMPONENT DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735213 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, WHILE MAPPING, THE ABLATION CATHETER ENCOUNTERED THE RIGHT BUNDLE BRANCH, RESULTING IN RIGHT BUNDLE BRANCH BLOCK (RBBB). THE EARLIEST POINT THAT NEEDED ABLATION WAS THE LEFT BUNDLE BRANCH. THE PHYSICIAN DECIDED NOT TO INTERVENE OR PERFORM SURGERY AS IT WAS BELIEVED THAT ADDITIONAL ABLATION COULD POTENTIALLY LEAD TO LEFT BUNDLE BRANCH BLOCK AND THIRD-DEGREE AV BLOCK. THERE WERE NO PERFORMANCE ISSUES WITH THE CATHETER. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE, AND NO FURTHER SURGERIES WERE SCHEDULED.

  Patient problems: Heart Block

  MAUDE report 23577637 ↗
• MalfunctionOct 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, IMPEDANCE AND TEMPERATURE ISSUES RESULTED IN CANCELLATION OF THE PROCEDURE. IT WAS NOTED THAT THE LEFT ATRIAL POSTERIOR WALL IMPEDANCE, WHICH SHOULD NOT BE HIGH, REACHED 130, WHILE THE ANTERIOR WALL IMPEDANCE WAS ONLY 110. MULTIPLE STEAM POPS WERE NOTED THROUGHOUT THE PROCEDURE. ELEVATED TEMPERATURES WERE ALSO NOTED. A REVIEW OF THE IMPEDANCE DROP AND TRANSIENT PRESSURE PARAMETERS SHOWED NO SIGNIFICANT ISSUES. THE PHYSICIAN WAS CONCERNED AND DECIDED THE PROCEDURE COULD NOT BE CONTINUED. CARDIOVERSION WAS COMPLETED AND THE PATIENT WAS SAFELY DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348413 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  DURING THE SVT PROCEDURE, THE CATHETER WAS INSERTED THROUGH AN INTRODUCER. DURING THE TREATMENT, THE SURGEON REMOVED THE CATHETER FOR SHAPING AND FOUND A CRACK AT THE TIP OF THE CATHETER. AFTER REPLACING THE ABLATION CATHETER, THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278008 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE IN THE CATHETER NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004299 ↗
• MalfunctionAug 28, 2025Fracture; Fracture

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER WAS INSERTED THROUGH AN INTRODUCER AND TREATMENT WAS STARTED. THE SURGEON REMOVED THE CATHETER FOR SHAPING AND A CRACK AT THE TIP OF THE CATHETER WAS OBSERVED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER HAD BEEN PROPERLY REMOVED FROM THE PACKAGING AND THE BENDING FUNCTION HAD BEEN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912078 ↗
• MalfunctionAug 21, 2025Fracture; Fracture

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER WAS NOTED TO BE FRACTURED. THE CATHETER WAS REMOVED FROM THE BODY AFTER THE INITIAL ABLATION. AFTER THE ELECTROPHYSIOLOGICAL STUDIES WERE PERFORMED THE CATHETER WAS REINSERTED FOR A SECOND ABLATION, IT WAS DISCOVERED THAT THE TIP WAS DAMAGED. NO ABNORMALITIES WERE FOUND DURING THE INITIAL ABLATION, AND CATHETER PRESSURES WERE NORMAL, SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AFTER THE CATHETER WAS REMOVED FROM THE BODY. 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 22865381 ↗
• MalfunctionJul 30, 2025Improper or Incorrect Procedure or Method; Optical Problem; Improper or Incorrect Procedure or Method; Optical Problem

  DURING THE PVC ABLATION PROCEDURE, OPTICAL PROBLEMS WITH THE TACTICATH CAUSED A DELAY. INITIALLY, THE ABLATION CATHETER WAS FUNCTIONING NORMALLY. HOWEVER, DUE TO THE NEED FOR CONTRAST IMAGING, CONTRAST MEDIUM WAS INJECTED THROUGH THE ABLATION CATHETER. FOLLOWING THIS, THE SYSTEM INDICATED A LOSS OF PRESSURE MONITORING. AFTER REPLACING THE TACTISYS QUARTZ ABLATION SYSTEM, THE ISSUE PERSISTED, AND THE ABLATION CATHETER REMAINED NON-FUNCTIONAL. WE SUBSEQUENTLY REPLACED THE ABLATION CATHETER, AFTER WHICH IT FUNCTIONED NORMALLY. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664177 ↗
• MalfunctionJul 11, 2025Material Separation; Material Separation

  DURING A CTI ABLATION PROCEDURE, THE TIP OF THE CATHETER DETACHED. WHEN THE TIP OF THE CATHETER WAS IN THE RIGHT ATRIUM, THE DISTAL TIP LOOKED WEAK. THE CATHETER WAS WITHDRAWN FROM THE PATIENT AND INVESTIGATED. A SLIGHT BEND WAS ENOUGH TO BREAK THE TIP OFF. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INTACT WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478694 ↗
• MalfunctionJun 23, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308114 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CHEST ULTRASOUND REVEALED A PERICARDIAL EFFUSION IN THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 22019344 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996236 ↗
• MalfunctionMay 1, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE NOTED IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945631 ↗
• MalfunctionApr 24, 2025Insufficient Heating; Insufficient Heating

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WERE TEMPERATURE ISSUES WITH THREE CATHETERS RESULTING IN A DELAY. THE FIRST CATHETER WAS INSERTED INTO THE PATIENT, AND THE TEMPERATURE WAS LOWER THAN EXPECTED. ABLATION WAS INITIATED ON THE LEFT POSTERIOR WALL OF THE LEFT ATRIUM, AND THE TEMPERATURE DROPPED TO 28C. AN ATTEMPT WAS MADE TO REINSERT THE CONNECTOR CABLE, WITH NO RESOLUTION. THE PN CABLE WAS EXCHANGED, AND THE ABLATION WAS INITIATED AGAIN; BUT THE TEMPERATURE DROPPED BELOW 30C. THE RF ABLATION GENERATOR WAS EXCHANGED, AND A SECOND ABLATION WAS ATTEMPTED, WITH NO RESOLUTION. TROUBLESHOOTING WAS ALSO DONE BY INCREASING ENERGY DELIVERY BEYOND 10 SECONDS, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AND INSERTED INTO THE PATIENT AND THE TEMPERATURE REMAINED LOWER THAN EXPECTED WITHOUT ABLATION AND PRESSURE READINGS WERE NOT DISPLAYED ACCURATELY. THE CONNECTOR CABLE WAS RE-INSERTED, WITH NO RESOLUTION. THE CASE WAS RESTARTED, BUT THE ISSUE REMAINED. THE TACTISYS SYSTEM WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE CATHETER WAS EXCHANGED AGAIN, AND THE BASELINE TEMPERATURE REMAINED LOW PRIOR TO ABLATION. WHEN ABLATION WAS ATTEMPTED, THE TEMPERATURE DROPPED BELOW 30C. REDUCING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902045 ↗
• MalfunctionApr 24, 2025Insufficient Heating; Insufficient Heating

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WERE TEMPERATURE ISSUES WITH THREE CATHETERS RESULTING IN A DELAY. THE FIRST CATHETER WAS INSERTED INTO THE PATIENT, AND THE TEMPERATURE WAS LOWER THAN EXPECTED. ABLATION WAS INITIATED ON THE LEFT POSTERIOR WALL OF THE LEFT ATRIUM, AND THE TEMPERATURE DROPPED TO 28C. AN ATTEMPT WAS MADE TO REINSERT THE CONNECTOR CABLE, WITH NO RESOLUTION. THE PN CABLE WAS EXCHANGED, AND THE ABLATION WAS INITIATED AGAIN; BUT THE TEMPERATURE DROPPED BELOW 30C. THE RF ABLATION GENERATOR WAS EXCHANGED, AND A SECOND ABLATION WAS ATTEMPTED, WITH NO RESOLUTION. TROUBLESHOOTING WAS ALSO DONE BY INCREASING ENERGY DELIVERY BEYOND 10 SECONDS, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AND INSERTED INTO THE PATIENT AND THE TEMPERATURE REMAINED LOWER THAN EXPECTED WITHOUT ABLATION AND PRESSURE READINGS WERE NOT DISPLAYED ACCURATELY. THE CONNECTOR CABLE WAS RE-INSERTED, WITH NO RESOLUTION. THE CASE WAS RESTARTED, BUT THE ISSUE REMAINED. THE TACTISYS SYSTEM WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE CATHETER WAS EXCHANGED AGAIN, AND THE BASELINE TEMPERATURE REMAINED LOW PRIOR TO ABLATION. WHEN ABLATION WAS ATTEMPTED, THE TEMPERATURE DROPPED BELOW 30C. REDUCING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902036 ↗
• MalfunctionApr 24, 2025Insufficient Heating; Insufficient Heating

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WERE TEMPERATURE ISSUES WITH THREE CATHETERS RESULTING IN A DELAY. THE FIRST CATHETER WAS INSERTED INTO THE PATIENT, AND THE TEMPERATURE WAS LOWER THAN EXPECTED. ABLATION WAS INITIATED ON THE LEFT POSTERIOR WALL OF THE LEFT ATRIUM, AND THE TEMPERATURE DROPPED TO 28C. AN ATTEMPT WAS MADE TO REINSERT THE CONNECTOR CABLE, WITH NO RESOLUTION. THE PN CABLE WAS EXCHANGED, AND THE ABLATION WAS INITIATED AGAIN; BUT THE TEMPERATURE DROPPED BELOW 30C. THE RF ABLATION GENERATOR WAS EXCHANGED, AND A SECOND ABLATION WAS ATTEMPTED, WITH NO RESOLUTION. TROUBLESHOOTING WAS ALSO DONE BY INCREASING ENERGY DELIVERY BEYOND 10 SECONDS, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AND INSERTED INTO THE PATIENT AND THE TEMPERATURE REMAINED LOWER THAN EXPECTED WITHOUT ABLATION AND PRESSURE READINGS WERE NOT DISPLAYED ACCURATELY. THE CONNECTOR CABLE WAS RE-INSERTED, WITH NO RESOLUTION. THE CASE WAS RESTARTED, BUT THE ISSUE REMAINED. THE TACTISYS SYSTEM WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE CATHETER WAS EXCHANGED AGAIN, AND THE BASELINE TEMPERATURE REMAINED LOW PRIOR TO ABLATION. WHEN ABLATION WAS ATTEMPTED, THE TEMPERATURE DROPPED BELOW 30C. REDUCING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902034 ↗
• MalfunctionApr 18, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE NOTED IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866246 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE / GOUGE NOTED IN THE SHAFT MATERIAL DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740258 ↗
• MalfunctionMar 27, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RELATED MANUFACTURE REF: 3005334138-2025-00171. DURING AN ATRIAL TACHYCARDIA PROCEDURE, A POSITIONING ISSUE OCCURRED AND A FRAY WAS NOTED CAUSING A PROCEDURE DELAY. IT WAS FOUND THAT THE ABLATION CATHETER WAS NOT BENT PROPERLY. ADDITIONALLY, THE TIP OF THE PUNCTURE SHEATH WAS ROUGH. THE SHEATH AND ABLATION CATHETER WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712425 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE TIP OF THE CATHETER WAS OBSERVED TO BE CRACKED. THE CATHETER HAD BEEN PROPERLY REMOVED FROM THE PACKAGING AND THE BENDING FUNCTION WAS NORMAL. THE CATHETER WAS INSERTED THROUGH AN INTRODUCER. DURING THE TREATMENT, THE SURGEON REMOVED THE CATHETER FOR SHAPING AND FOUND A CRACK AT THE TIP OF THE CATHETER. 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 21707014 ↗
• InjuryMar 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  FOLLOWING THE ATRIAL FIBRILLATION (PVI) PROCEDURE, A PERICARDIAL EFFUSION WAS DIAGNOSED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. DURING THE PROCEDURE, WITH THE CATHETER IN THE LEFT ATRIUM, THE SE POINT OF THE CATHETER WAS CONTINUOUSLY DISPLAYED IN RED AND THE FOLLOWING ERROR MESSAGE WAS DISPLAYED: "CATHETER IN PORT SE1 HAS A MAGNETIC SENSOR ISSUE. CHECK CONNECTIONS AND CONSIDER REPLACING THE CATHETER OR ITS CABLE." ALL CONNECTIONS WERE CHECKED, WITH NO RESOLUTION. NO ABLATION HAD BEEN PERFORMED YET. THE CATHETER WAS EXCHANGED WHICH RESOLVED THE ISSUE AND THE PROCEDURE CONTINUED. DURING THE PROCEDURE, FLUCTUATING BLOOD PRESSURE VALUES (FROM 147/82 TO 78/43 MMHG) WERE REPEATEDLY NOTED, WHICH WERE INTERPRETED AS A REACTION TO THE ANESTHESIA AFTER RULING OUT A PERICARDIAL EFFUSION VIA ULTRASOUND. THE HEART ANATOMY WAS NOTED TO BE SOMEWHAT COMPLICATED, AND SOME STRUCTURES WERE NOT ABLE TO BE CORRECTLY ASSIGNED ON THE MODEL. THE PHYSICIAN WANTED TO PROCEED WITH THE ABLATION, DESPITE THE RECOMMENDATION TO CONTINUE COLLECTING GEOMETRY DATA TO GET A BETTER ORIENTATION. AFTER PERFORMING THE ABLATION, BECAUSE THE VEINS APPEARED TO BE SIGNAL ISOLATED, THE PHYSICIAN DECLARE

  Patient problems: Cardiac Perforation

  MAUDE report 21506207 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS EXPOSING INTERNAL WIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432928 ↗