TactiSys™ PN-004400Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 07640157990194), received between Jun 27, 2018 and Sep 25, 2026 — classified as 16 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (75 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 5, 2019Terminated

   In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.

   Z-1493-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Optical Problem

  During a repeat pulmonary vein isolation procedure for atrial fibrillation using the TactiSys Quartz System, the contact force on the TactiFlex Duo Catheter could not be reset and signals displayed on the EnSite X System appeared purple. Verification of system connections, system restart, and exchange of two TactiFlex Duo Catheters did not resolve the issue. Subsequent use of a TactiFlex SE Catheter also did not resolve the issue, and the procedure was cancelled.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898569 ↗
• MalfunctionFeb 26, 2026Communication or Transmission Problem

  DURING A TYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A TACTISYS ISSUE WHILE THE PATIENT PREPARED ON THE TABLE. WHEN PREPPING FOR THE TACTIFLEX ABLATION CATHETER, IT WAS NOTED THAT THE TACTISYS QUARTZ WAS BLINKING RED AND WOULD NOT CONNECT TO THE ENSITE X SYSTEM. TROUBLESHOOTING INCLUDED CHECKING AND RESEATING ALL THE CONNECTIONS, POWERING THE TACTISYS QUARTZ OFF AND ON, CONFIRMING THAT THE CORRECT SERIAL NUMBER WAS ENTERED INTO THE SYSTEM, AND OPENING A NEW CATHETER, BUT THE ISSUE PERSISTED. A TACTISYS WAS BORROWED FROM ANOTHER ACCOUNT, WHICH TOOK ABOUT 15 MINUTES. EVERYTHING WAS PLUGGED IN AGAIN, THE TACTISYS DISPLAYED A GREEN LIGHT AND PROPERLY CONNECTED TO THE MAPPING SYSTEM. THE PROCEDURE WAS THEN COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461864 ↗
• MalfunctionJan 3, 2026Optical Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, OPTICAL ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THERE WERE NO CONTACT FORCE VALUES. THE CATHETER WAS REPLACED THREE TIMES BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT CONTACT FORCE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952948 ↗
• MalfunctionNov 11, 2025Optical Problem; Optical Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, CONTACT FORCE ISSUES RESULTED IN A PROCEDURAL DELAY. THE TACTISYS WAS REBOOTED, AND THE CATHETER WAS EXCHANGED, BUT THE ISSUE PERSISTED. EXCHANGING THE TACTISYS RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528807 ↗
• MalfunctionNov 3, 2025Optical Problem; Optical Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE THERE WAS A CONTACT FORCE ISSUE WITH THE TACTISYS RESULTING IN A DELAY. DUE TO THIS ISSUE WHEN THE TACTICATH SE CATHETER WAS CONNECTED THE CONTACT FORCE DID NOT DISPLAY. THE PROCEDURE WAS DELAYED FOR AN HOUR WHILE WAITING FOR A REPLACEMENT TACTISYS. AFTER REPLACING THE TACTISYS THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459770 ↗
• MalfunctionSep 12, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WERE ISSUES WITH NOISE ON THE ECG RESULTING IN CANCELLATION OF THE PROCEDURE. MAPPING AND ABLATION WERE PERFORMED, BUT CONSOLIDATION WAS NEEDED. THE PATIENT HAD BEEN SEDATED DURING ABLATION AS THEY WERE EXPERIENCING PAIN. THE PRS-PS MOVED SO MAPPING WAS PERFORMED AGAIN. AT THIS TIME, THERE WAS A LOT OF NOISE ON THE ECG. THE NOISE WAS NOT ABLE TO BE RESOLVED, AND IT WAS DECIDED TO END THE PROCEDURE DUE TO NOT BEING ABLE TO MAP AND PACE THE PREMATURE VENTRICULAR CONTRACTION. IT IS UNKNOWN WHAT WAS CAUSING THE ISSUE. UPON CLEAN UP THE NOISE ON THE ECG DISAPPEARED WHEN REMOVING THE TACTIFLEX CABLE FROM THE TACTISYS. THE CABLE WAS RECONNECTED, BRINGING BACK THE NOISE, AND THEN DISCONNECTED AND THE NOISE RESOLVED ONCE AGAIN. IT IS UNKNOWN WHAT WAS CAUSING THIS AS THE TACTIFLEX WAS USED FOR MAPPING AT THE BEGINNING OF THE PROCEDURE WITHOUT ISSUE. THE TACTISYS AND TACTIFLEX TO TACTISYS CABLE HAVE BOTH BEEN USED IN PROCEDURES SINCE WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042718 ↗
• MalfunctionSep 9, 2025Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS NO CONTACT FORCE FROM THE TACTIFLEX CATHETER. THE CATHETERS AND CABLES WERE EXCHANGED AND MULTIPLE REBOOTS WERE DONE. ADDITIONALLY, THE FIBER PORT WAS CLEANED WITH NO RESOLUTION AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006632 ↗
• MalfunctionJul 29, 2025Optical Problem; Optical Problem

  DURING THE PVC PROCEDURE, OPTICAL ISSUES WITH THE TACTISYS RESULTED IN A PROCEDURAL DELAY. THE ABLATION CATHETER WAS INSERTED INTO THE HEART CHAMBER AND CONNECTED TO THE TACTISYS AND ENSITE, HOWEVER THE CONTACT FORCE VALUE WAS NOT DISPLAYED ON THE ENSITE. THE TACTIFLEX CATHETER WAS RECONNECTED TO THE TACTISYS, AND THE TACTISYS, ENSITE AMPLIFIER, AND ENSITE DWS WERE ALL RESTARTED, BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE TACTISYS AND WITHOUT CONTACT FORCE BEING DISPLAYED AND WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THE PROCEDURE, THE ISSUE WAS RESOLVED BY REPLACING THE TACTISYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642339 ↗
• MalfunctionJun 13, 2025Optical Problem; Optical Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE TACTISYS QUARTZ COULD NOT BE BROUGHT TO ZERO, AND THE CONTACT FORCE WAS NOT DISPLAYED ON THE SCREEN (REMAINED PURPLE). THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202540 ↗
• MalfunctionJun 5, 2025Optical Problem; Optical Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER TRANSSEPTAL PUNCTURE, IT WAS NOTED THAT THE TACTISYS QUARTZ COULD NOT BE BROUGHT TO ZERO, AND NO CONTACT FORCE WAS DISPLAYED ON THE SCREEN. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150135 ↗
• MalfunctionMay 30, 2025Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AN OPTICAL ISSUE OCCURRED CAUSING A DELAY. IT WAS NOT POSSIBLE TO ZERO THE FORCE ON THE TACTISYS. ANOTHER ABLATION CATHETER WAS OBTAINED WHICH DID NOT RESOLVE THE ISSUE. A SAFIRE CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE. A LOANER TACTISYS WAS USED THE FOLLOWING DAY WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114480 ↗
• MalfunctionMay 23, 2025Optical Problem; Optical Problem

  DURING AN ATRIAL FIBRILLATION / ATRIAL FLUTTER PROCEDURE, OPTICAL AND IMPEDANCE ISSUES OCCURRED, AND THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT THE CONTACT FORCE VALUES WOULD INTERMITTENTLY GO IN AND OUT. THE CATHETER WAS REPLACED WHICH SEEMED TO RESOLVE THE ISSUE, BUT THEN CONTACT FORCE VALUES APPEARED INCORRECT. IT WAS ALSO REPORTED THAT THE IMPEDANCE VALUE ON THE AMPERE GENERATOR WAS DISPLAYED AS 999. A THIRD CATHETER WAS INTRODUCED, AND THE TACTIFLEX RF CABLE WAS REPLACED, BUT THE ISSUE PERSISTED, AND THE PROCEDURE WAS ABANDONED. IT WAS UNKNOWN AS TO WHETHER THE TACTISYS OR THE AMPERE GENERATOR CAUSED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078090 ↗
• MalfunctionMay 13, 2025Optical Problem; Optical Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE TACTISYS DID NOT DISPLAY CONTACT FORCE VALUES CAUSING A PROCEDURE DELAY. DIFFERENT CATHETERS WERE TRIED, AND THE SYSTEM WAS REBOOTED WHICH DID NOT RESOLVE THE ISSUE. THE TACTISYS WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012789 ↗
• MalfunctionMay 6, 2025Optical Problem; Optical Problem

  DURING THE SVT PROCEDURE, AN OPTICAL PROBLEM OCCURRED CAUSING A PROCEDURE DELAY. IT WAS NOTED THE CONTACT FORCE VALUES WERE NOT ABLE TO BE SEEN. EXCHANGING THE CATHETER DID NOT RESOLVE THE ISSUE. THE TACTISYS WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969599 ↗
• MalfunctionApr 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, A COMMUNICATION ISSUE OCCURRED RESULTING IN CANCELLATION OF THE PROCEDURE. DURING THE PROCEDURE, THE TACTISYS ICON SHOWED AS GREY ON THE ENSITE X USER INTERFACE, INDICATING IT WAS UNABLE TO SEARCH OR CONNECT TO THE TACTISYS UNIT. ABLATION AND ELECTROGRAMS WERE VISIBLE ON THE MAP, BUT NO FORCE DATA. THE CASE WAS ABANDONED DUE TO TEMPORARY AV BLOCK WITH PHYSICAL 'BUMP'. THE ENSITE AMPLIFIER AND TACTISYS WERE POWERED DOWN AND COMMUNICATION WAS RESTORED WHEN POWERED BACK UP. THE NEXT CASE HAD NO ISSUES WITH COMMUNICATION AND IS WORKING AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911816 ↗
• MalfunctionMar 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE TACTISYS UNIT WOULD NOT CONNECT TO THE ENSITE SYSTEM. REBOOTING THE SYSTEM AND RESEATING THE CONNECTIONS DID NOT RESOLVE THE ISSUE. TWO TACTIFLEX CATHETERS WERE USED DURING TROUBLESHOOTING BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT (CARTO) SYSTEM AND NON-ABBOTT (BIOSENSE) ABLATION CATHETER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618879 ↗
• MalfunctionMar 17, 2025Calibration Problem; Calibration Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, CALIBRATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. THE ABLATION CATHETER WAS CONNECTED TO THE TACTISYS AND BEFORE INSERTING THE CATHETER INTO THE PATIENT, AN ERROR DISPLAYED STATING, "TACTISYS QUARTZ CALIBRATION HAS EXPIRED AND CANNOT BE USED." THERE WAS NO COMMUNICATION WITH THE ENSITE X SYSTEM AND NO CONTACT FORCE OR VISUALIZATION OF THE CATHETER. EVERY DEVICE WAS TURNED OFF AND THEN BACK ON AND THE CONNECTIONS WERE ALL CHECKED BUT THE ISSUE PERSISTED. THERE WAS NOT A REPLACEMENT TACTISYS AVAILABLE SO THE PROCEDURE WAS CANCELLED. THE PROCEDURE HAS BEEN RESCHEDULED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618750 ↗
• MalfunctionDec 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PREMATURE VENTRICULAR TACHYCARDIA (PVC) ABLATION PROCEDURE IN THE VOXEL MODE, A COMMUNICATION ISSUE OCCURRED CAUSING A DELAY. THE TACTISYS WAS POWERED ON AND PHYSICALLY CONNECTED TO THE CATHETER AND AMPLIFIER, BUT WAS NOT RECOGNIZED BY THE ENSITE X SYSTEM, AND DID NOT DISPLAY CONTACT FORCE. ALL CONNECTIONS WERE DOUBLE CHECKED AND RESTARTED, THE TACTISYS TO AMPERE ETHERNET CORD WAS REPLACED, AND THE TACTISYS SERIAL NUMBER WAS DELETED AND REENTERED INTO ENSITE X. DESPITE THOSE STEPS, THE TACTISYS WOULD NOT CONNECT. A DIFFERENT TACTISYS FROM ANOTHER LAB IN THE HOSPITAL USED TO AND IMMEDIATELY CONNECTED AND FUNCTIONED PROPERLY. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891858 ↗
• MalfunctionDec 3, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING AN ATRIAL FIBRILLATION PROCEDURE, SELF-TEST ISSUES RESULTED IN THE CANCELLATION OF THE PROCEDURE. WHILE VALIDATING THE ENSITE PATCHES, IT WAS NOTED THAT THE TACTISYS WAS NOT CONNECTED TO THE ENSITE. THE POWER SOURCE AND NETWORK CABLE WERE CHANGED. THE EQUIPMENT WAS RESTARTED BUT IT DID NOT PASS THE SELF-TEST. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE HAS BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831734 ↗
• MalfunctionNov 19, 2024Optical Problem; Optical Problem

  DURING A CARDIO NEURO ABLATION PROCEDURE, AN OPTICAL ISSUE OCCURRED CAUSING A DELAY IN PROCEDURE. THE CATHETER CONTACT FORCE WAS OUT OF RANGE WHEN THE CATHETER WAS CONNECTED. THE CONNECTION WAS CHECKED, AND THE CATHETER WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE. A NEW TACTISYS WAS USED AND THE PROCEDURE WAS COMPLETED AND THERE WERE NOT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724581 ↗
• MalfunctionOct 14, 2024Optical Problem; Optical Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WAS A CONTACT FORCE ISSUE WITH THE TACTISYS RESULTING IN A DELAY OF PROCEDURE. WHEN CONNECTING THE ABLATION CATHETER THERE WAS NO CONTACT FORCE DISPLAYED. THE TACTISYS WAS RESTARTED AND RE-CONNECTED AND THE ABLATION CATHETER WAS REPLACED WITH NO RESOLVE. THE TACTISYS WAS THEN EXCHANGED, AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES USING THE LAST CATHETER CONNECTED. THE CATHETER WILL NOT BE RETURNED BECAUSE THE PATIENT WAS ISOLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443209 ↗
• MalfunctionOct 7, 2024Optical Problem; Optical Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, WHEN CONNECTING THE TACTIFLEX ABLATION CATHETER TO THE TACTISYS QUARTZ, AFTER INSERTION INTO THE PATIENT, IT DID NOT SHOW THE CONTACT FORCE VALUES, RESULTING IN A DELAY. THE TACTIFLEX ABLATION CATHETER WAS REPLACED BUT THE ISSUE REMAINED. THE TACTISYS QUARTZ WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392885 ↗
• MalfunctionSep 23, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TACTISYS HAD A COMMUNICATION ISSUE WHICH RESULTED IN A CANCELLATION OF PROCEDURE. WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, IT WAS NOTED THAT THE TACTISYS WOULD NOT CONNECT. THE ETHERNET CABLE BETWEEN THE TACTISYS ON THE AMPLIFIER WAS RESEATED AND SWAPPED BUT WITH NO RESOLUTION. THE TACTISYS TO AMPERE CABLE WAS ALSO REPLACED BUT WITH NO RESOLUTION. THE PROCEDURE WAS THEN CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281842 ↗
• MalfunctionJun 17, 2024Optical Problem; Optical Problem

  DURING AN ACCESSORY PATHWAY PROCEDURE, A CONTACT FORCE ISSUE WITH TWO TACTISYS UNITS RESULTED IN A DELAY TO THE PROCEDURE. AFTER COMPLETING THE 1.7.2 UPGRADE ON THE TACTISYS (FIRST CASE AFTER THE UPGRADE), CONTACT FORCE WAS UNABLE TO BE OBTAINED ON FOUR DIFFERENT TACTIFLEX SE CATHETERS AND TWO TACTISYS UNITS. INITIALLY, THE FIRST TACTIFLEX SE WAS CONNECTED TO THE TACTISYS. CONTACT FORCE WAS DETECTED BUT WAS OUT OF RANGE AND WOULD NOT RESET. NEXT, A SECOND TACTIFLEX SE WAS CONNECTED TO TACTISYS AND THE SAME ISSUE OCCURRED. NEXT, A THIRD TACTIFLEX SE WAS CONNECTED TO A DIFFERENT TACTISYS AND THE SAME ISSUE OCCURRED. THE THIRD TACTIFLEX SE WAS THEN CONNECTED TO THE ORIGINAL TACTISYS AND THE ISSUE PERSISTED. LASTLY, A FOURTH TACTIFLEX SE WAS CONNECTED TO BOTH TACTISYS UNITS WITH NO RESOLUTION. CABLES WERE CHECKED, CONNECTED, AND RECONNECTED. THE ENSITE X DWS AND TACTISYS UNITS WERE POWER CYCLED, AND THE AMPLIFIER WAS ALSO RESTARTED TWICE DURING TROUBLESHOOTING. THE CASE WAS RESTARTED WITH NO RESOLUTION. A SAFIRE TX WAS UTILIZED WITHOUT ISSUE TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. LATER, BOTH TACTISYS UNITS WERE TESTED WITH NUMEROUS CATHETERS IN A NON-CLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554104 ↗
• MalfunctionJun 17, 2024Optical Problem; Optical Problem

  DURING AN ACCESSORY PATHWAY PROCEDURE, A CONTACT FORCE ISSUE WITH TWO TACTISYS UNITS RESULTED IN A DELAY TO THE PROCEDURE. AFTER COMPLETING THE 1.7.2 UPGRADE ON THE TACTISYS (FIRST CASE AFTER THE UPGRADE), CONTACT FORCE WAS UNABLE TO BE OBTAINED ON FOUR DIFFERENT TACTIFLEX SE CATHETERS AND TWO TACTISYS UNITS. INITIALLY, THE FIRST TACTIFLEX SE WAS CONNECTED TO THE TACTISYS. CONTACT FORCE WAS DETECTED BUT WAS OUT OF RANGE AND WOULD NOT RESET. NEXT, A SECOND TACTIFLEX SE WAS CONNECTED TO TACTISYS AND THE SAME ISSUE OCCURRED. NEXT, A THIRD TACTIFLEX SE WAS CONNECTED TO A DIFFERENT TACTISYS AND THE SAME ISSUE OCCURRED. THE THIRD TACTIFLEX SE WAS THEN CONNECTED TO THE ORIGINAL TACTISYS AND THE ISSUE PERSISTED. LASTLY, A FOURTH TACTIFLEX SE WAS CONNECTED TO BOTH TACTISYS UNITS WITH NO RESOLUTION. CABLES WERE CHECKED, CONNECTED, AND RECONNECTED. THE ENSITE X DWS AND TACTISYS UNITS WERE POWER CYCLED, AND THE AMPLIFIER WAS ALSO RESTARTED TWICE DURING TROUBLESHOOTING. THE CASE WAS RESTARTED WITH NO RESOLUTION. A SAFIRE TX WAS UTILIZED WITHOUT ISSUE TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. LATER, BOTH TACTISYS UNITS WERE TESTED WITH NUMEROUS CATHETERS IN A NON-CLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554094 ↗