NaviStar ThermoCool NI75TCDHRecalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 10846835000559), received between Oct 4, 2016 and Sep 28, 2026 — classified as 20 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (15 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, 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 ↗
• MalfunctionAug 20, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358279 ↗
• 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 ↗
• 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°C. ELECTROGRAM SIGNALS SHOWED AV BLOCK IN ONE HEARTBEAT, AFTER THAT THE ABLATION WAS STOPPED. THE QRS COMPLEX WAS WIDER THAN BEFORE ABLATION AND CONDUCTION TO THE VENTRICLE WAS VIA ACCESSORY PATHWAY. THE PATIENT HAD 45 MINUTES OF THIRD-DEGREE AV BLOCK. AV CONDUCTION RETURNED AFTER A WAITING PERIOD. BEFORE STARTING THE ABLATION, THE CATHETER CAUSED A BLOCK IN THE ACCESSORY PATHWAY AND AT THE SAME TIME THERE WAS NO VISIBLE HIS BUNDLE SIGNAL ON THE MAPPING 1-2 OR 3-4 CHANNELS. THE DISTANCE TO THE HIS CATHETER WAS ALSO CHECKED WITH FLUOROSCOPY. THEREFORE, IT WAS THOUGHT THAT IT WAS SAFE TO START THE ABLATION. NO SURGERY DELAY REPORTED DUE TO THE EVENT. THE PATIENT¿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 ↗
• 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 ↗
• MalfunctionJan 3, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A NAVISTAR THERMOCOOL CATHETER AND THE IRRIGATION ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON PATIENT. OCCLUSION/ NO IRRIGATION. 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 PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 10-DEC-2024. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE IS THE CATHETER. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. NO ERROR, DURING THE PROCEDURE, THERE WAS A HIGH TEMPERATURE READING. WITHDRAWING THE CATHETER, FOUND THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE. THEY MANUALLY PRESSURIZED DRAINAGE TO INCREASE FLOW RATE TO RESOLVE THE ISSUE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH THE FLOW RATE CHANGE AT THE START OF ABLATION. ADDITIONAL INFORMATION WAS RECEIVED ON 18-DEC-2024. THE TEMPERATURE CUT OFF VALUE WAS EXCEEDED. HOWEVER, THE SYSTEM STOPPED THE ABLATION WHEN THE CUT-OFF VALUE WAS EXCEEDED. THE GENERATOR WAS SET TO POWER CONTROL MODE, 48, 40W, 25ML/S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068081 ↗
• MalfunctionNov 11, 2024Partial Blockage; Partial Blockage

  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 WITH INTERNAL PARTS EXPOSED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED INADEQUATE IRRIGATION 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 (B)(6) 2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEEK HOUSING WAS BROKEN WITH INTERNAL PARTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651331 ↗
• MalfunctionOct 29, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) OBSERVED THE PEEK HOUSING WAS BENT AND BROKEN. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE DEFLECTION ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON (B)(6) 2024, THE PEEK HOUSING WAS BENT AND BROKEN THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 03-OCT-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561696 ↗
• MalfunctionOct 18, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) OBSERVED THAT THE PEEK HOUSING WAS BROKEN. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, THERE WAS HIGH TEMPERATURE READING FROM THE CATHETER WHEN RADIOFREQUENCY (RF) IS BEING DELIVERED. THE TEMPERATURE CUT-OFF VALUE WAS EXCEEDED, AND THE SYSTEM STOPPED THE ABLATION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE HIGH TEMPERATURE CUT-OFF EXCEEDED (ABLATION STOPPED) ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 24-SEP-2024, THE PEEK HOUSING WAS OBSERVED BROKEN. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 24-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486114 ↗
• MalfunctionOct 2, 2024Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) OBSERVED THAT THE PEEK HOUSING WAS BROKEN WITH WIRES EXPOSED. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, THE CATHETER WAS RECOGNIZED BY THE CARTO SYSTEM, HOWEVER, THE ICON DIRECTION WAS OPPOSITE ON THE SCREEN. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE REVERSE ICON ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 05-SEP-2024, THE PEEK HOUSING WAS OBSERVED BROKEN WITH WIRES EXPOSED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 05-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352656 ↗
• MalfunctionSep 10, 2024Insufficient 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 (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THE PUMP DID NOT HAVE ANY PROBLEMS, BUT THE TEMPERATURE WAS HIGH DURING DISCHARGE. AFTER WITHDRAWAL, IT WAS FOUND THAT THE CONDUIT COULD NOT FLUSH. THE CATHETER WAS SUSPECTED AS THE ISSUE DURING THE EVENT. THE ISSUE WAS NOTED AFTER THE DEVICE WAS USED ON 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 20182400 ↗
• MalfunctionAug 22, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED, THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) CARDIAC ABLATION PROCEDURE. WITH A NAVISTAR THERMOCOOL AND MIDWAY THROUGH ABLATION. THE THERMOCOUPLE HOLES OF THE CATHETER WERE STUCK AND THE ABLATION COULD NOT BE IRRIGATED. MULTIPLE ATTEMPTS TO FLUSH THE CATHETER WAS PERFORMED AND FAILED TO UNCLOG THE THERMOCOUPLE HOLES. THEY REPLACED THE CATHETER WITH A NEW ONE. AND THE CASE CONTINUED WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028681 ↗
• MalfunctionAug 12, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB AND IDENTIFIED THAT THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. DURING THE PROCEDURE, THERE WAS A DEFLECTION ISSUE. THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. 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 19958944 ↗
• MalfunctionJun 28, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEBAX BROKEN. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED DEFLECTION 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 5-JUN-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEEK HOUSING BROKE WITH EXPOSED WIRES. THESE FINDINGS WERE REVIEWED AND ASSESSED THIS AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635134 ↗
• MalfunctionJun 17, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEEK HOUSING BROKEN. DURING THE PROCEDURE, THERE IS NO TEMPERATURE DISPLAYED ON THE CARTO OR GENERATOR. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 20-MAY-2024, THE PEEK HOUSING WAS BROKEN. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE PEEK HOUSING BROKEN ON 20-MAY-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553689 ↗
• MalfunctionMay 23, 2024Obstruction 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 BEFORE THE OPERATION, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THERE WAS NO ERROR NOTED FROM THE IRRIGATION PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. 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 19383428 ↗
• MalfunctionApr 16, 2024Obstruction 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 AN IRRIGATION INADEQUATE ISSUE OCCURRED. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ON 19-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED WHICH MADE THIS EVENT MDR REPORTABLE. IT WAS CONFIRMED THAT THE SUSPECTED DEVICE WAS THE CATHETER, AND THE DEVICE WAS USED ON PATIENT. THE ISSUE WAS DISCOVERED WHEN THEY NOTED THE ABNORMAL TEMPERATURE SENSOR. THE STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS BY USING A SYRINGE FOR IRRIGATION. CORRECT CATHETER SETTINGS WERE USED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113548 ↗
• MalfunctionMar 29, 2024Obstruction 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 MID-PROCEDURE. THERE WERE NO ERRORS OR INCORRECT SETTINGS NOTED ON THE PUMP AND GENERATOR. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005809 ↗
• MalfunctionMar 26, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE STERILIZATION PACKAGE WAS BROKEN. IT WAS REPORTED THE PRIMARY PACKAGE WAS DAMAGED. BEFORE THE OPERATION, THE STERILIZATION PACKAGE WAS BROKEN. THE SEAL OF THE PRIMARY PACKAGE WAS FOUND BROKEN AFTER THE CARTON WAS OPENED. THE DEVICE INSIDE WAS CONTAMINATED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE WAS NOT USED IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983447 ↗
• MalfunctionMar 25, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. THE CATHETER WAS REMOVED FROM THE PATIENT, THE TIP WAS CLEANED, AND HIGH FLOW WAS USED TO FLUSH. HOWEVER, THE ISSUE WAS NOT RESOLVED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P