NaviStar ThermoCool NI75TCJHRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835000573), received between May 1, 2018 and Aug 25, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 73-YEAR-OLD FEMALE PATIENT (59KG) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE THAT REQUIRED A PERICARDIOCENTESIS. THERE WAS A STEAM POP. IT WAS REPORTED THAT A STEAM POP OCCURRED IN THE LEFT ATRIAL APPENDAGE DURING ABLATION. THEY WERE ABLATING AT 45 WATTS WHEN THE STEAM POP OCCURRED. THE STEAM POP OCCURRED ON THE FIRST OR SECOND ABLATION. THERE WAS NO VISIBLE CHAR ON THE CATHETER. THE FLOW RATE OF THE CATHETER WAS APPROPRIATE AND THE CATHETER WAS FLUSHED PRIOR TO ABLATION. THE TEMPERATURE READINGS DISPLAYED ON THE CARTO 3 SYSTEM ON AND OFF ABLATION WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT ENDED UP WITH CARDIAC TAMPONADE AND A PERICARDIOCENTESIS WAS DONE. THERE WERE 200 CCS OF FLUID WAS REMOVED AND THE PATIENT WAS STABLE. THE PATIENT STAYED OVERNIGHT WITH THE DRAIN IN PLACE. THE DRAIN WAS REMOVED EARLIER TODAY AND THE PATIENT DID NOT REQUIRE ANY SURGICAL REPAIR. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS A BWI PRODUCT MALFUNCTION. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFF

  Patient problems: Cardiac Tamponade

  MAUDE report 15290835 ↗
• InjuryApr 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT (B)(6) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION, AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT WHILE ABLATING IN THE LEFT ATRIAL APPENDAGE, THE PHYSICIAN FELT A STEAM POP. THE PATIENT HAD A SLIGHT DROP IN THEIR BLOOD PRESSURE. THE PATIENT HAD A PERICARDIAL EFFUSION THAT WAS CONFIRMED VIA THE ICE CATHETER. THE PATIENT HAD A PERICARDIOCENTESIS AND 5.5 LITERS OR 5500 CCS OF FLUID WAS REMOVED. CARDIOVASCULAR SURGEONS WERE STANDING BY. THEY WERE ABLE TO CLOSE THE LEFT ATRIAL APPENDAGE WITH A CLOSURE DEVICE TO STOP THE EFFUSION. THE PATIENT WAS STABLE DURING THE ENTIRE PROCEDURE. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION IN THE ICU. THE PHYSICIAN FELT THE EFFUSION WAS FROM THE STEAM POP THAT OCCURRED AT THE BASE OF THE APPENDAGE. THEY USED A MAXIMUM OF 45 WATTS DURING THE ABLATION. ADDITIONAL INFORMATION WAS RECEIVED ON 13-MAR-2022. THE LOT NUMBER IS UNKNOWN AS THE CATHETER PACKAGING WAS THROWN AWAY. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS IMPROVED. THE PATIENT REQUIRED EXTEND

  Patient problems: Cardiac Tamponade

  MAUDE report 14041818 ↗
• InjuryJan 11, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 460ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN STATED THEY HAD A SMALL STEAM POP ABLATING THE FLOOR OF THE LEFT ATRIUM. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE IS THAT IT WAS CAUSED BY THE PROCEDURE ¿ STEAM POP AT FLOOR OF LEFT ATRIUM (LA). THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS; FFP, AND K-CENTRA GIVEN. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED (NO RESIDUAL EFFECTS). GENERATOR INFORMATION: SMARTABLATE, (B)(4). A TRANSSEPTAL PUNCTURE WAS PERFORMED. NEEDLE PRODUCT DETAILS: BAYLIS STANDARD C0; REF # (B)(4). PRIOR TO NOTING THE PE OR CT ABLATION WAS PERFORMED. THE EV

  Patient problems: Cardiac Tamponade

  MAUDE report 13219846 ↗
• InjuryOct 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION OF THE LEFT ATRIAL APPENDAGE, A STEAM POP OCCURRED. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 865 CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS RELATED TO THE PATIENT CONDITION AND THE STEAM POP. TRANSSEPTAL PUNCTURE WAS PERFORMED USING A SL1 TRANSSEPTAL NEEDLE. AN IMPEDANCE MAX ERROR MESSAGE WAS OBSERVED ON THE GENERATOR. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, VISITAG, DASHBOARD AND VECTOR. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 3 MM FOR 5 SEC, AND TAG SIZE 2 MM, NO ADDITIONAL FILTERS WERE USED. THE COLOR OPTION USED PROSPECTIVELY WAS FORCE AND TIME. THE STEAM POP IS NOT CONSIDERED TO BE A DEVICE MALFUNCTION. STEAM POP IS

  Patient problems: Cardiac Tamponade

  MAUDE report 9183050 ↗
• InjuryAug 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR-OLD MALE PATIENT WITH HISTORY OF 3 PREVIOUS ABLATION PROCEDURES, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND THE PHYSICIAN HEARD A STEAM POP. AT THIS TIME, THERE WAS A SUDDEN IMPEDANCE SPIKE/DROP. CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 800 CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. EXTENDED HOSPITALIZATION WAS REQUIRED, FOR MONITORING PURPOSES. THE PATIENT¿S OUTCOME WAS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO THE STEAM POP EXPERIENCED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BAYLIS NRG TRANSSEPTAL NEEDLE, STANDARD CURVE C0 (CATALOG/REF NRG-E-HF-71-C0). THE FLOW WAS SET AT 30 ML/MIN. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. EQUIPMENT DURING THE PROCEDURE. THE PARAMETERS FOR STABILITY USED WITH THE

  Patient problems: Cardiac Tamponade

  MAUDE report 8928746 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. FOUR HOURS POST-PROCEDURE, WHILE IN THE RECOVERY ROOM, A PERICARDIAL EFFUSION WAS CONFIRMED VIA ECHOCARDIOGRAPHY. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. THERE IS NO INFORMATION REGARDING THE PATIENT¿S CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. THERE IS NO INFORMATION REGARDING THE PATIENT¿S OUTCOME. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE PATIENT¿S AGE AND EXTENSIVE LEFT ATRIAL APPENDAGE (LAA) ABLATION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PROCEDURE AND THE PATIENT¿S CONDITION. IT WAS NOTED THAT THE INJURY MOST LIKELY OCCURRED DURING ABLATION PHASE. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS MEDICAL TRANSSEPTAL NEEDLE. THERE IS NO SHEATH INFORMATION. GENERATOR WAS SET ON POWER CONTROL MODE AT 40-47 W

  Patient problems: Cardiac Tamponade

  MAUDE report 7478382 ↗

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-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-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-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-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-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