TactiSysRecalls & reported problems across all models

We found 2 models of TactiSys by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Sep 25, 2026 — classified as 16 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (75 reports).

1 FDA recall record 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

TactiSys 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. 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 TactiSys problems

TactiSys models

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

• TactiSys™ PN-004400

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall125 reports
• TactiSys™ PN-004515

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

Recent TactiSys adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionOct 1, 2025Failure to Power Up; Communication or Transmission Problem; Failure to Power Up; Communication or Transmission Problem

  DURING A PROCEDURE, THERE WAS AN AMPERE GENERATOR BOOT UP ISSUE AND AN ERROR DISPLAYED STATING "GENERATOR MALFUNCTION". RESTARTING THE AMPERE GENERATOR DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS THEN CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23187806 ↗
• 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 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls