EZ Steer ThermoCool NAV BNI75TCFJHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835003376), received between Apr 11, 2018 and Oct 18, 2024 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A EZ STEER THERMOCOOL NAV AND THE CATHETER COULD NOT FLUSH. THE CATHETER WAS THE DEVICE SUSPECTED TO HAVE THE FLOW/IRRIGATION ISSUE AS IT WAS IN THE HEART FOR SOME TIME INSIDE WITHOUT BEING IRRIGATED BY MISTAKE. THE IRRIGATION ISSUE WAS DISCOVERED WHEN THEY TRIED TO ABLATE (HIGHER IRRIGATION RATE) AND THEY HAD BUBBLES ERROR SO THEY CHECKED THE CATHETER OUTSIDE THE PATIENT AND THE CATHETER DID NOT FLUSH. THEY TRIED TO CHANGE THE IRRIGATION SYSTEM AND FLUSH WITH THE PUMP AND MANUALLY THE CATHETER OUTSIDE THE BODY. ONLY AFTER REPLACING THE CATHETER COULD THEY CONTINUE THE PROCEDURE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482977 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER, AND THE PATIENT SUFFERED A CARDIAC TAMPONADE. DURING THE MAPPING PHASE, THE PATIENT HAD A CARDIAC TAMPONADE. THE PHYSICIAN SOLVED THE PROBLEM, AND THE PATIENT WAS OK. IT IS UNKNOWN WHAT INTERVENTION WAS PERFORMED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION OF AN EXTRA DAY FOR MONITORING. PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE IRRIGATION WAS SET FOR 2ML/MIN AS THIS WAS MAPPING PHASE. THERE WAS NO TRANSSEPTAL PUNCTURE PERFORMED. NO ABLATION WAS PERFORMED. NO STEAM POP WAS NOTICED PRIOR TO THE EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 9585995 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVC) WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPH (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT OVERNIGHT AND THEN REQUIRED 2 EXTRA DAYS OF HOSPITALIZATION IN THE REGULAR NURSING FLOOR. PATIENT¿S OUTCOME IS FULLY RECOVERED. PATIENT¿S ANATOMY WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. A ST. JUDE MEDICAL SHORT GROIN ACCESS SHEATH 8.5 FR WAS USED. THE GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH A MAXIMUM POWER OF 50 WA

  Patient problems: Cardiac Tamponade

  MAUDE report 7866012 ↗
• InjuryMay 22, 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 ATRIAL FLUTTER WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED A HEART BLOCK AV REQUIRING A SURGICAL INTERVENTION. DURING ABLATION, THE PATIENT WENT INTO COMPLETE HEART BLOCK. REMAINDER OF PROCEDURE WAS ABORTED. A PERMANENT PACEMAKER WAS INSERTED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 7534330 ↗
• DeathApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR INAPPROPRIATE SINUS TACHYCARDIA (IST) WITH ANEZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED A HEART BLOCK AV (REQUIRING PACING) AND DEATH. DURING THE PROCEDURE, SINUS NODE MODIFICATION/ABLATION WAS PERFORMED FOR A TOTAL OF 1 MINUTE. PATIENT BECAME HYPOXIC AND BRADYCARDIC. IT WAS NOTED THAT THE BRADYCARDIA SEEMED UNRELATED TO THE RADIOFREQUENCY ABLATION. PACING WAS INITIATED VIA THE CORONARY SINUS (CS) CATHETER. PATIENT CONTINUED TO DETERIORATE AND AN ATRIOVENTRICULAR BLOCK WAS OBSERVED. PATIENT WAS INTUBATED. PACING WAS SWITCHED FROM THE CS CATHETER TO THE RIGHT VENTRICULAR (RV) CATHETER. THE RV STOPPED CAPTURING AND THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA (VT), WHICH PROGRESSED TO VENTRICULAR FIBRILLATION (VF). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. PHARMACOLOGIC SUPPORT WAS PROVIDED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PROCEDURE AND/OR THE PATIENT¿S CONDITION. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING T

  Patient problems: Arrhythmia; Death

  MAUDE report 7423939 ↗

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-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-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