TactiCath™ A-TCSE-DDRecalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 05415067027634), received between Apr 3, 2019 and Mar 13, 2026 — classified as 14 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Fracture” (35 reports).

1 FDA recall record name this device's 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, 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THIS PER IS INITIATED FROM AN ADVERSE INCIDENT REPORT SUBMITTED BY (B)(6) HOSPITAL DIRECTLY TO CHINA MEDICAL DEVICE AE REPORTING SYSTEM (HTTP://MAERS.ADRS.ORG.CN). THE SJM NOTIFIED WAS MADE AWARE ON NOV 10, 2025 FROM THE SYSTEM. PLEASE MAKE THIS A COMPLAINT PRODUCT SO A REGULATORY REPORT CAN BE SUBMITTED TO NMPA. DURING THE SVT PROCEDURE, COMMUNICATION ISSUES WITH THE CATHETER RESULTED IN A PROCEDURAL DELAY. WHEN PREPARING TO CONNECT THE CATHETER TO THE TAIL WIRE, THE PRESSURE DISPLAY WAS NORMAL. AFTER THE PRESSURE WAS LOWERED TO ZERO OUTSIDE THE BODY, THE CATHETER WAS INSERTED INTO THE BODY. PRIOR TO ABLATION, THE CATHETER APPEARED RED AND REMAINED STATIONARY BUT HAD A POTENTIAL. RESTARTING THE AMPLIFIER AND THE DWS DID NOT RESOLVE THE ISSUE. REPLACING THE ABLATION CATHETER RESOLVED THE ISSUE WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744213 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. MODELING WAS DONE USING AN ADVISOR HD GRID MAPPING CATHETER THEN, THE ABLATION CATHETER WAS USED FOR SUPPLEMENTARY MODELING IN THE RIGHT PULMONARY VEIN. WHILE MODELING WITH THE ABLATION CATHETER, PRESSURE WAS SHOWN TO BE AROUND 10G. THE IMPEDANCE SUDDENLY INCREASED TO 200 OHMS. LOOKING AT THE IMAGE, IT APPEARED THAT THE CATHETER HAD PERFORATED THE RIGHT UPPER PULMONARY VEIN. THE PATIENT'S BLOOD PRESSURE DROPPED AND AN X-RAY WAS DONE WHICH CONFIRMED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE CAUSE OF THE PERFORATION WAS PRIMARILY DUE TO CATHETER MANIPULATION BY THE SURGEON. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23451250 ↗
• MalfunctionJul 29, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE CATHETER SHAPE DID NOT DISPLAY ON THE 3D DISPLAY. THE TACTISYS AND CABLE WERE CHANGED 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 22642441 ↗
• MalfunctionJul 7, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, DEFLECTION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS FOUND THAT THE TIP OF THE CATHETER WAS BENT. THE CATHETER WAS REPLACED BUT THE SECOND CATHETER COULD NOT BE DEFLECTED. THE SECOND 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 22418060 ↗
• MalfunctionJul 7, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, DEFLECTION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS FOUND THAT THE TIP OF THE CATHETER WAS BENT. THE CATHETER WAS REPLACED BUT THE SECOND CATHETER COULD NOT BE DEFLECTED. THE SECOND 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 22414611 ↗
• MalfunctionJun 24, 2025Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER WAS FOUND TO HAVE A CRACK IN THE TIP. WHEN THE POTENTIAL WAS ABNORMAL THE CATHETER WAS TAKEN OUT OF THE BODY, AND THE CRACK WAS NOTED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323725 ↗
• MalfunctionMay 21, 2025Fracture; Optical Problem; Fracture; Optical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060950 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CRACK WAS NOTED AT THE TIP OF THE CATHETER. THE ABLATION CATHETER WAS INSERTED AND THEN REMOVED. PRIOR TO REINSERTING IT, A CRACK WAS NOTED 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 22013908 ↗
• MalfunctionMar 19, 2025Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  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 21645199 ↗
• MalfunctionNov 22, 2024Fracture; Optical Problem; Fracture; Optical Problem

  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 20761630 ↗
• MalfunctionNov 19, 2024Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN PREPARING TO ISOLATE THE PULMONARY VEINS, A FRACTURE WAS FOUND BETWEEN THE 2ND AND 3RD ELECTRODES OF THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724999 ↗
• MalfunctionNov 1, 2024Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS AN OPTICAL ISSUE THAT RESULTED IN A DELAY. THE ERROR MESSAGE "NO CONTACT FORCE SIGNAL OR SIGNAL OUT OF RANGE" WAS DISPLAYED AFTER THE CATHETER WAS CONNECTED. THE CATHETER OPTICAL CONNECTIONS WERE CHECKED. "PLEASE CONTACT SJM TECHNICAL SUPPORT" ALSO DISPLAYED. CHECKING THE CATHETER OPTICAL CONNECTION AGAIN AND RECONNECTING AND RESTARTING THE ENSITE PRECISION SYSTEM ALSO DID NOT RESOLVE THE ISSUE. 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 20588051 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560351 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524035 ↗
• MalfunctionOct 12, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435052 ↗
• MalfunctionSep 20, 2024Overheating of Device; Optical Problem; Overheating of Device; Optical Problem

  RELATED MANUFACTURING REF: (B)(4). DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AN OPTICAL ISSUE OCCURRED CAUSING A DELAY IN PROCEDURE. THE CATHETER WAS CONNECTED TO THE TACTISYS, BUT THE PRESSURE DID NOT DISPLAY NORMALLY, INDICATING THAT THE CATHETER WAS NOT CONNECTED. THE TACTISYS MODULE AND RADIO FREQUENCY INSTRUMENT WERE RESTARTED, AND THE CATHETER WAS RESEATED WITH NO RESOLUTION. THE CATHETER WAS THEN REPLACED AND THE PRESSURE SHOWED NORMALLY. HOWEVER, DURING THE PROCEDURE, THE TEMPERATURE WAS NOT AS EXPECTED AND DURING ABLATION, THE TEMPERATURE WAS 39-40 DEGREES CELSIUS. DURING ABLATION, THE PRESSURE GRADUALLY INCREASED WITH THE RADIOFREQUENCY ABLATION TIME. THE CATHETER WAS REPLACED AGAIN AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271620 ↗
• MalfunctionAug 6, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925400 ↗
• MalfunctionJul 18, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776055 ↗
• InjuryJul 18, 2024Optical Problem; Optical Problem

  DURING THE PREMATURE VENTRICULAR CONTRACTIONS ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. AFTER CONNECTING THE TAIL LINE OF THE ABLATION CATHETER, IT WAS FOUND THAT THE THREE-DIMENSIONAL SYSTEM COULD NOT DISPLAY THE PRESSURE VALUE. THE TEMPERATURE AND IMPEDANCE VALUES WERE DISPLAYED NORMALLY. THE PRESSURE MODULE WAS RESTARTED BUT THE THREE-DIMENSIONAL SYSTEM STILL COULD NOT DISPLAY THE PRESSURE VALUE. SINCE THERE WERE NO SPARE ABLATION CATHETERS AND PRESSURE MODULES AT THE TIME, THE PHYSICIAN CHOSE TO CONTINUE THE OPERATION. THE ABLATION CATHETER WAS SUCCESSFULLY POSITIONED IN THE RIGHT VENTRICULAR OUTFLOW TRACT NEAR THE SEPTAL SIDE AFTER FEMORAL VEIN PUNCTURE. THE RELATIVELY EARLY POTENTIAL WAS MAPPED AND THE RADIOFREQUENCY INSTRUMENT SHOWED THAT THE TEMPERATURE AND IMPEDANCE AT THE TIP OF THE ABLATION CATHETER WERE NORMAL VALUES. AFTER ATTEMPTING ABLATION DISCHARGE FOR 60 SECONDS, THE PATIENT'S BLOOD PRESSURE VALUE WAS NOTED TO DROP RAPIDLY AND THE BASAL HEART RATE DROPPED TO 40 BEATS/MINUTE. SINCE THE PATIENT WAS UNDER LOCAL ANESTHESIA, THE PATIENT'S CONSCIOUSNESS GRADUALLY BECAME BLURRED. UNDER X-RAY FLUOROSCOPY,

  Patient problems: Cardiac Perforation

  MAUDE report 19774600 ↗
• MalfunctionJul 16, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THERE WAS SIGNAL INTERFERENCE, RESULTING IN A DELAY OF PROCEDURE. THE AMPLIFIER, DISPLAY WORKSTATION, AND MULTICONDUCTOR WERE RESTARTED, AND THE CABLES AND CONNECTIONS WERE CHECKED, BUT 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 19756510 ↗