NaviStar ThermoCoolRecalls & reported problems across all models

We found 5 models of NaviStar ThermoCool by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 168 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2016 and Sep 28, 2026 — classified as 44 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (23 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. 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

Most reported NaviStar ThermoCool problems

NaviStar ThermoCool models

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

• NaviStar ThermoCool NI75TCDH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  111 reports
• NaviStar ThermoCool NI75TCFH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  36 reports
• NaviStar ThermoCool NI75TCBH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  11 reports
• NaviStar ThermoCool NI75TCJH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  6 reports
• NaviStar ThermoCool NI75TCCH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  4 reports

Recent NaviStar ThermoCool adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922044 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that during a clinical study Atrial Fibrillation (AFIb) case, the patient suffered complete heart block requiring surgical intervention. Patient received an index cardiac ablation for ventricular tachycardia. On (b)(6) 2026, patient experienced complete heart block (AE#1), categorized as moderate and serious, defined by hospitalization with an admission date of (b)(6) 2026 and a discharge date of (b)(6) 2026. Relationship to study device is probable (NAVISTAR THERMOCOOL AND OPTRELL CATHETERS) and relationship to the index study procedure is probable. The adverse event is anticipated. The outcome is resolved with an end date of (b)(6) 2026. Intervention was surgery (Upgrade to a CRT-D "[Cardiac Resynchronization Therapy Defibrillator]" System. Patient had already a 1 Chamber -ICD "[Implantable Cardioverter-Defibrillator]").

  Patient problems: Heart Block

  MAUDE report 50871199 ↗
• MalfunctionAug 20, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358279 ↗
• MalfunctionMar 11, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON INTRACARDIAC (IC) CHANNELS ON BOTH THE CARTO3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN DID HAVE OTHER INTACT ECG SIGNALS AVAILABLE TO MONITOR PATIENT HEART RHYTHM. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED NOISE ON IC SIGNALS IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 18-FEB-2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574434 ↗
• MalfunctionFeb 20, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEEK HOUSING WAS BROKEN. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON INTRACARDIAC CHANNELS (IC) ON THE CARTO 3 SYSTEM WHILE THE CATHETER WAS INSIDE THE PATIENT¿S BODY. SIGNAL INTERFERENCE OF MAP1-2 WAS OBSERVED. THERE WAS OTHER SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED NOISE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 26-JAN-2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEEK HOUSING WAS BROKEN. THIS FINDING WAS REVIEWED AND ASSESSED AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403172 ↗
• MalfunctionNov 24, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL CATHETER AND THE MEDICAL TEAM FOUND INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. NO ERROR MESSAGES WERE NOTED PRIOR TO THE ISSUE. THE ISSUE WAS DISCOVERED SINCE THE TEMPERATURE ABNORMALLY INCREASED, RESULTING IN THE INABILITY TO DISCHARGE. AFTER REMOVING THE CATHETER FROM THE PATIENT'S BODY, THE SURGEON OPENED THE THREE-WAY VALVE AND ACTIVATED THE FAST-FLUSHING FUNCTION OF THE PUMP AND FOUND THAT THE CATHETER TIP COULD NOT RELEASE WATER. THE THREE-WAY VALVE CAN DISCHARGE WATER, SO IT IS DETERMINED THAT THERE IS A PROBLEM WITH THE PIPELINE. THE CORRECT SETTINGS WERE SELECTED ON THE GENERATOR. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635923 ↗
• InjurySep 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOLFF-PARKINSON-WHITE (WPW) AND MID-SEPTAL ACCESSORY PATHWAY ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL, THE PATIENT HAD 45 MINUTES OF THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK. THE PATIENT RECEIVED ONLY ONE ABLATION. ABLATION DURATION 7 SECONDS AT 40 WATTS, HIGH FLOW 17 ML/MIN WITH A MAXIMUM TEMPERATURE OF ABOUT 37°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¿S CONSEQUENCE WAS TEMPORARY AV BLOCK. NO MEDICAL INTERVENTION NOTED. THERE WAS NO PROBLEM WITH THE CATHETER. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT

  Patient problems: Heart Block

  MAUDE report 23017610 ↗
• MalfunctionSep 9, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL AND IT WAS NOT IRRIGATING DURING USE ON THE PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED OCCLUSION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 25-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE NAVISTAR THERMOCOOL WAS USED ON THE PATIENT AND THERE WERE NO ERRORS GIVEN BY THE IRRIGATION PUMP. THE DEVICE WAS RE-ENTERED INTO THE PATIENT'S BODY, THEY FOUND NO IRRIGATION. TO TROUBLESHOOT THEY TRIED HIGH FLOW IRRIGATION AND WIPED THE CATHETER TIP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THE EVENT OCCURRED WHILE THE DEVICE WAS IN THE PATIENT¿S BODY, THE EVENT HAS BEEN REASSESSED AS AN MDR REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002118 ↗
• MalfunctionSep 5, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA / WOLFF-PARKINSON-WHITE (WPW) SYNDROME ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982859 ↗
• MalfunctionJun 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THERE WERE NO ERROR MESSAGES. THE CORRECT CATHETER SETTINGS WERE SELECTED. NO FLOW RATE CHANGES WERE NOTED AT THE START OF ABLATION. THE ISSUE WAS NOT IDENTIFIED UNTIL THE DEVICE HAD BEEN USED INSIDE OF THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196464 ↗
• MalfunctionApr 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL AND AN IRRIGATION ISSUE OCCURRED IN THE FORM OF A BLOCKAGE. THE IRRIGATION ISSUE WAS NOT NOTED PRIOR TO THE PROCEDURE, BUT ONLY AFTER THE DEVICE HAD BEEN USED ON THE PATIENT. THE CATHETER WAS REMOVED FROM THE BODY MOMENTARILY IN PREPARATION FOR FURTHER USAGE, HOWEVER, THAT WAS WHEN THE MEDICAL TEAM NOTED THE BLOCKAGE. NO ERROR MESSAGES WERE NOTED IN RELATION TO THE ISSUE. HIGH-FLOW FLUSHING WAS ATTEMPTED TO REMOVE THE BLOCKAGE BUT THE ISSUE PERSISTED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853425 ↗
• MalfunctionMar 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BROKEN TIP. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, THE TIP OF THE DEVICE WAS FOUND DAMAGED. THERE WERE NO WIRES BEING EXPOSED, NOR ANY LIFTED OR SHARP RINGS. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THIS WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 19-FEB-2025, THE TIP WAS PARTIALLY DETACHED FROM THE DEVICE, WITH WIRES EXPOSED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 19-FEB-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21639927 ↗
• MalfunctionMar 7, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE WAS NOT FLUSHING CORRECTLY. THE ISSUE WAS NOTED AFTER THE MEDICAL TEAM HAD STARTED THE FIRST ABLATION. SOME OF THE IRRIGATION HOLES FELT LIKE THEY WERE PLUGGED. THEY REMOVED THE CATHETER FROM THE PATIENT'S BODY AND NOTED THAT THREE OF THE IRRIGATION HOLES WERE CLOGGED AND NOT FLUSHING PROBABLY. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS ALSO SET CORRECTLY AS WELL. HOWEVER, THE TEMPERATURE ROSE AS SOON AS ABLATION STARTED. THE CATHETER WAS REPLACED. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551359 ↗
• MalfunctionFeb 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A SMARTABLATE AND AN IRRIGATION ISSUE OCCURRED WHICH WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. OCCLUSION/ NO IRRIGATION. IT WAS REPORTED THAT DURING THE PROCEDURE, DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15-JAN-2025. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. CONNECTED THE TC (THERMOCOOL) AND DID NOT FLUSH PROPERLY. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS TO FLUSH THE TC WITH 50ML SYRINGE. DISCONNECTED THE TC AND FLUSHED NORMALLY. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2025. THE DEVICE WAS USED ON THE PATIENT DURING NORMAL USE AND DID NOT ENTER THE PATIENT AFTER THE PUMP TUBE CLOGGED. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 15-JAN-2025 THAT THE IRRIGATION ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381255 ↗
• InjuryFeb 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. CARDIAC TAMPONADE OCCURRED DURING LVOT (LEFT VENTRICULAR OUTFLOW TRACT) PVC ABLATION. NO CARDIAC SURGERY WAS NECESSARY. THE PERICARDIAL EFFUSION STOPPED AFTER PERICARDIAL PUNCTURE. PATIENT FULLY RECOVERED. PROCEDURE DETAILS INCLUDE: TEMPERATURE CONTROLLED MODE, 40W. 3 LESIONS, MAX. ABLATION TIME 43S, MAX. TEMPERATURE 39°C. INITIAL MAX. IMPEDANCE 229OHM, NO ABRUPTLY DROP/RISE BUT MAX. DROP OF 67OHM OVER 10S. THERE WAS NO EVIDENCE OF STEAM POP.

  Patient problems: Cardiac Tamponade

  MAUDE report 21349602 ↗

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