NaviStar ThermoCool NI75TCCHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835008357), received between Aug 29, 2022 and Jun 27, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KULAKOWSKI P, BARAN J, SIKORSKA A, KRYNSKI T, NIEDZWIEDZ M, SOSZYNSKA M, PIOTROWSKI R. CARDIONEUROABLATION FOR REFLEX ASYSTOLIC SYNCOPE: MID-TERM SAFETY, EFFICACY, AND PATIENT'S ACCEPTANCE. HEART RHYTHM. 2024 MAR;21(3):282-291. DOI: 10.1016/J.HRTHM.2023.11.022. EPUB 2023 NOV 29. PMID: 38036236. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: CARDIONEUROABLATION (CNA) IS A PROMISING THERAPY FOR REFLEX ASYSTOLIC SYNCOPE; HOWEVER, CONVINCING DATA ON THE MID-TERM SAFETY AND EFFICACY OF THIS PROCEDURE ARE LACKING. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO ASSESS THE MID-TERM SAFETY, EFFICACY, AND PATIENT ACCEPTANCE OF CNA. METHODS: THIS PROSPECTIVE OBSERVATIONAL SINGLE-CENTER STUDY INCLUDED 115 CONSECUTIVE PATIENTS (MEAN AGE 39 ± 13 YEARS; 58% FEMALE) TREATED BETWEEN 2016 AND 2022 WHO COMPLETED AT LEAST 1-YEAR FOLLOW-UP. RESULTS: NO SIGNIFICANT PROCEDURE-RELATED ACUTE COMPLICATIONS OCCURRED. DURING MEDIAN FOLLOW-UP OF 28 MONTHS (RANGE 12-75), 95 (83%) REMAINED FREE FROM SYNCOPE. OF THE 20 PATIENTS (17%) WITH SYNCOPE RECURRENCE, SYNCOPE BURDEN DECREASED FROM A MEAN 17 (MEDIAN 6.5) TO 3.75 (MEDIAN 2.5

  Patient problems: Arrhythmia; Chest Pain; Dyspnea; Fatigue

  MAUDE report 19625850 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HAN Y, SHAO M, YANG H, SUN H, SANG W, WANG L, WANG L, YANG S, JIAN Y, TANG B, LI Y. SAFETY AND EFFICACY OF CARDIONEUROABLATION FOR VAGAL BRADYCARDIA IN A SINGLE ARM PROSPECTIVE STUDY. SCI REP. 2024 MAR 11;14(1):5926. DOI: 10.1038/S41598-024-56651-9. PMID: 38467744; PMCID: PMC10928196. OBJECTIVE/METHODS/STUDY DATA: CARDIONEUROABLATION (CNA) IS CURRENTLY CONSIDERED AS A PROMISING TREATMENT OPTION FOR PATIENTS WITH SYMPTOMATIC BRADYCARDIA CAUSED BY VAGOTONIA. THIS STUDY AIMS TO FURTHER INVESTIGATE ITS SAFETY AND EFFICACY IN PATIENTS SUFFERING FROM VAGAL BRADYCARDIA. A TOTAL OF 60 PATIENTS WITH VAGAL BRADYCARDIA WHO UNDERWENT CNA IN THE FIRST AFFILIATED HOSPITAL OF XINJIANG MEDICAL UNIVERSITY FROM NOVEMBER 2019 TO JUNE 2022. PREOPERATIVE ATROPINE TESTS REVEALED ABNORMAL VAGAL TONE ELEVATION IN ALL PATIENTS. FIRST, THE ELECTROANATOMIC STRUCTURES OF THE LEFT ATRIUM WAS MAPPED OUT BY USING THE CARTO 3 SYSTEM, ACCORDING TO THE PROTOCOL OF PURELY ANATOMY-GUIDED AND LOCAL FRACTIONATED INTRACARDIAC ELECTROGRAM-GUIDED CNA METHODS. THE UPPER LIMIT OF ABLATION POWER OF SUPERIOR LEFT GANGLION (SLGP) AND R

  Patient problems: Heart Block

  MAUDE report 19618083 ↗
• MalfunctionJun 6, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEFLECTION MECHANISM WAS STUCK. 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. ADDITIONAL INFORMATION RECEIVED INDICATED THE CATHETER WAS STUCK IN A DEFLECTED POSITION. THE FAILURE WAS FOUND DURING USE AND THERE WAS NO RING OR ELECTRODE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481423 ↗
• InjuryAug 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: TAKAMATSU S, TACHIBANA M, II N, HASUI Y, MATSUMOTO K, BANBA K. PROPER USE OF FENTANYL FACILITATES ANESTHESIA DURING PULMONARY VEIN ISOLATION. HEART VESSELS. 2022 JUN;37(6):1034-1043. DOI: 10.1007/S00380-021-02001-Y. EPUB 2022 JAN 7. PMID: 34993585. OBJECTIVE/METHODS/STUDY DATA: THE AUTHORS AIMED TO CLARIFY THE OPTIMAL FENTANYL DOSAGE AND TIMING OF ADMINISTRATION FOR THE ANESTHETIC MANAGEMENT DURING PVI. A TOTAL OF 364 PATIENTS WITH ATRIAL FIBRILLATION (AF) WHO UNDERWENT PVI AT OUR INSTITUTION BETWEEN JUNE 2017 AND OCTOBER 2020 WERE RECRUITED. ALL PATIENTS WERE ANESTHETIZED WITH PROPOFOL FOR INDUCTION AND MAINTENANCE UNDER CONTROLLED VENTILATION VIA THE SUPRAGLOTTIC AIRWAY WITHOUT NEUROMUSCULAR BLOCKING DRUGS. AMONG THEM, 234 PATIENTS RECEIVED LESS FREQUENT INJECTIONS (GROUP 1) AND 130 RECEIVED A SCHEDULED INJECTION OF 50 MG OF FENTANYL (GROUP 2) IN ADDITION TO PROPOFOL DURING PVI. THE MEAN PATIENT AGE WAS 67.2 YEARS, AND 69% WERE MALE. THE TOTAL PROPOFOL DOSE WAS SIGNIFICANTLY LOWER IN GROUP 2 THAN IN GROUP 1 (17.0¿±¿5.2 MG/KG VS. 19.0¿±¿5.5 MG/KG, P¿<¿0.01). THE LOADING DOSE AND FREQUE

  Patient problems: Paralysis; Paresis; Stroke/CVA

  MAUDE report 15316210 ↗

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-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-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-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-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