EZ Steer ThermoCool NAVRecalls & reported problems across all models

We found 3 models of EZ Steer ThermoCool NAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2016 and Sep 29, 2026 — classified as 3 deaths, 31 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (21 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 EZ Steer ThermoCool NAV problems

EZ Steer ThermoCool NAV models

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

• EZ Steer ThermoCool NAV BNI75TCDFH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 deaths35 reports
• EZ Steer ThermoCool NAV BNI75TCFJH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death5 reports
• EZ Steer ThermoCool NAV BNI75TCDDH

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

Recent EZ Steer ThermoCool NAV adverse event reports

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

• InjurySep 29, 2026Device Sensing Problem; Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50941066 ↗
• MalfunctionSep 25, 2026Delivered as Unsterile Product

  It was reported that a patient underwent a cardiac ablation procedure and when the medical team opened a EZ Steer ThermoCool NAV, "the product was contaminated upon opening". The device was not used inside of the patient's body. A new EZ Steer was opened. Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available to clarify the exact 'contamination', its potential source, or the condition of the packaging.No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903476 ↗
• InjuryAug 25, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with an EZ Steer ThermoCool NAV catheter and the patient experienced cardiac tamponade which required pericardiocentesis.Toward the end of the premature ventricular contraction ablation, it was noticed that the patient had developed a pericardial effusion on intracardiac echocardiogram. At one point, the patient's blood pressure dropped significantly. A pericardiocentesis was performed to drain the effusion, and the patient's blood was "auto-transfused." The patient's blood pressure recovered, they were stable and awake when case was completed. Because of the volume of blood that was transfused, the decision was made to transport the patient to the surgical unit. Current patient status was stable.Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50435340 ↗
• MalfunctionDec 23, 2025Insufficient Cooling; Obstruction of Flow; High Readings; Insufficient Cooling; Obstruction of Flow; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER THERMOCOOL NAV CATHETER AND THE SMARTABLATE PUMP KIT-WW. THE CATHETER HAD BLOCKED CHANNELS (DEVICE USED IN PATIENT). TEMPERATURE AND IMPEDANCE NOT ACTING AS EXPECTED. IT SEEMED LIKE THE CATHETER HAD BLOCKED CHANNELS. TOOK SOME PICTURES FROM ABLATION. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. THE TEMPERATURE VALUE WAS DISPLAYED HIGH. THE SYSTEM STOPPED THE ABLATION WHEN THE CUT OFF VALUE EXCEEDED. THE SMARTABLATE GENERATOR WAS USED WITH DEFAULT THERMOCOOL SETTINGS. THE IMPEDANCE VALUE DISPLAYED AT BOTH HIGH AND LOW. THE SYSTEM STOPPED ACCORDINGLY. CONFIRMATION RECEIVED INDICATED THAT THE ¿BLOCKED CHANNELS¿ REFERRED TO AN IRRIGATION ISSUE. THE SUSPECTED DEVICE FOR THE FLOW / IRRIGATION ISSUE WAS THOUGHT TO BE THE PUMP MALFUNCTIONING. THE EZ STEER THERMOCOOL NAV CATHETER WAS USED IN THE PATIENT. NO ERRORS, JUST PROBLEMS WITH TEMPERATURE AND IMPEDANCE. NEW PUMP WAS USED. THE SMARTABLATE GENERATOR KIT-WW AND SMARTABLATE PUMP KIT-WW WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882887 ↗
• InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING CARDIAC ABLATION WITH EZ STEER THERMOCOOL NAV CATHETER, THE PATIENT EXPERIENCED DROP IN BLOOD PRESSURE, CARDIAC ARREST, CARDIAC TAMPONADE TREATED WITH CARDIOPULMONARY RESUSCITATION AND DRAINAGE. AFTER INTRODUCING PERCUTANEOUS CARDIOPULMONARY SUPPORT, THORACOTOMY WAS PERFORMED AND PERFORATION WAS NOTED AT THE LATERAL SIDE OF THE BASE OF LEFT VENTRICLE. AFTER COMPLETING ABLATION AT THE CUSP, DURING PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED, LEADING TO CARDIAC ARREST, AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. CARDIAC TAMPONADE WAS REPORTED AND DRAINAGE WAS CONDUCTED, AND VITALS TEMPORARILY STABILIZED, BUT THEN DETERIORATED AGAIN. AFTER INTRODUCING PERCUTANEOUS CARDIOPULMONARY SUPPORT, THORACOTOMY WAS PERFORMED. THE ABLATION SITES WERE THE CUSP AND NEAR THE LEFT VENTRICULAR OUTFLOW TRACT, 25-30W FOR 60 SECONDS. ABLATION CATHETER WAS A TC (TACTICATH BY ABOTT, SO THERE WAS NO CONTACT FORCE MEASUREMENT). VISUAL IMPDROP INDICATOR SHOWED ABLATION, AND DURING THE FINAL ABLATION, THERE WAS NO EXCESSIVE IMPEDANCE DECREASE OR INCREASE. EXTENDED HOSPITALIZATION WAS NOTED. VISITAG COLORING SETTING WAS TOTAL TIME. THE PHYSICIAN'S OPINIONS ON TH

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 23762449 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CATHETER ABLATION OF THE SLOW PATHWAY (CASP) PROCEDURE WITH AN EZ STEER THERMOCOOL NAV CATHETER, THE PATIENT EXPERIENCED A CARDIAC BLOCK TREATED WITH INSERTION OF TEMPORARY PACEMAKER. DURING THE PROCEDURE FOR PVC FROM THE LEFT LEG, DURING ABLATION FROM CATHETER ABLATION OF THE SLOW PATHWAY (CASP), BRADYCARDIA AND CARDIAC BLOCK OCCURRED WHEN THE DECANAV CATHETER SHIFTED BELOW THE VALVE. A TEMPORARY PACEMAKER WAS INSERTED, AND THE PATIENT WAS UNDER FOLLOW-UP OBSERVATION. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. NO PROLONGATION OF HOSPITAL STAY WAS NOTED. THE CONTACT FORCE (CF) MONITORING METHOD WAS VISITAG. THE COLORING SETTING OF VISITAG WAS TAG INDEX. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS NO CAUSAL RELATIONSHIP. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS NOT RELATED TO THE PRODUCTS.

  Patient problems: Heart Block

  MAUDE report 23317942 ↗
• MalfunctionAug 7, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A LIFTED ELECTRODE ALONG WITH A PULLER WIRE BROKEN INSIDE OF THE HANDLE. NO INTERNAL COMPONENTS WERE EXPOSED. DURING THE PROCEDURE, THE DOCTOR WAS ADJUSTING THE CURVE IN THE CHAMBER WHEN THE KNOB BROKE, MAKING IT IMPOSSIBLE TO TURN TO THE D CURVE. NO ERROR CODE OCCURRED. 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 22745577 ↗
• InjuryJun 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A EZ STEER THERMOCOOL NAV, THE PATIENT EXPERIENCED TAMPONADE TREATED WITH PERICARDIOCENTESIS. TACHYCARDIA STARTED (350MS, CS1-2 FIRST). LOCAL ACTIVATION TIME (LAT) MAP OF LEFT ATRIUM (LA) WITH ABLATION CATHETER (THERMOCOOL) STARTED. LAT MAPPING OF THE LA WITH ABLATION CATHETER, FAST ANATOMICAL MAPPING (FAM) WAS CREATED IN A STRUCTURE IN THE RIGHT ANTERIOR SUPERIOR SIDE OF THE LA. THE PHYSICIAN THOUGHT IT WAS A SMALL ROOF VEIN. EARLY POINT APPEARED BETWEEN RIGHT SUPERIOR PULMONARY VEIN (RSPV) AND THIS UNKNOWN STRUCTURE. PHYSICIAN TRIED TO ABLATE IN BETWEEN, BUT CATHETER WAS FALLING INTO THIS STRUCTURE, AND ABLATION WAS BEING STOPPED DUE TO HIGH TEMPERATURE. IMPEDANCE WAS NORMAL. PHYSICIAN TOOK THE ABLATION CATHETER OUT AND INJECTED CONTRACT IN THIS UNKNOWN STRUCTURE, AND REALIZED IT WAS NOT A SMALL ROOF VEIN. AN ECHO FOUND THE TAMPONADE, AND PERICARDIOCENTESIS WAS PERFORMED. PATIENT BLOOD PRESSURE BECAME STABLE, AND PROCEDURE FINISHED. THE PHYSICIAN BELIEVED TAMPONADE WAS CREATED DURING MAPPING WITH ABLATION CATHETER. AT THE START OF THE PROCEDURE, THE PHYSICIAN HAD PROBLEMS WITH THE TRANSSEPTAL,

  Patient problems: Cardiac Tamponade

  MAUDE report 22293710 ↗
• MalfunctionMar 24, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND THERE WAS CHARRING ON SIDE OF THE TIP ELECTRODE. THE PHYSICIAN CONSIDERED THE AMOUNT OF CHARRING TO PRESENT A PATIENT RISK. THERE WERE NO ISSUES RELATED TO THE CATHETER, PUMP, AND GENERATOR SETTINGS. THE PATIENT WAS ANTICOAGULATED WITH AN ACTIVATED CLOTTING TIME (ACT) OF 300 MAINTAINED THROUGHOUT THE CASE. NO ERROR MESSAGES OR PRODUCT PROBLEMS WERE NOTED. DETAILS REGARDING TROUBLESHOOTING OR THE COMPLETION OF THE PROCEDURE WERE NOT PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682958 ↗
• MalfunctionOct 29, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND THERE WAS AN IRRIGATION ISSUE. THE MEDICAL TEAM NOTED THAT THE TEMPERATURE WAS TOO HIGH DURING ABLATION (OVER 40). THEN THEY NOTICED THAT THE IRRIGATION HOLE WAS BLOCKED DURING FLUSH. THE ISSUE WASN'T NOTED UNTIL THE DEVICE WAS BEING USED ON THE PATIENT. THE TEAM REMOVED THE DEVICE FROM THE PATIENT AND ATTEMPTED TO FLUSH, WHICH WAS WHEN THEY FOUND THE IRRIGATION BLOCKAGE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO FLOW RATE CHANGE ISSUES NOTED AT THE START OF ABLATION. THE CATHETER WAS CHANGED AND THE TEMPERATURE NORMALIZED AGAIN. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563431 ↗
• 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 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. RF NEEDLE WAS NOT USED FOR TRANSSEPTAL PUNCTURE. ABLATION WAS PERFORMED. ONE HOUR AFTER THE PROCEDURE WAS STARTED AND DURING THE ABLATION, IMPEDANCE INCREASED MID-ABLATION. THE ABLATION WAS IMMEDIATELY STOPPED, BUT THE BLOOD PRESSURE DECREASED. NO STEAM POPS HAVE BEEN CONFIRMED. PERICARDIAL DRAINAGE WAS PERFORMED AND BLOOD PRESSURE WAS STABILIZED. THE PATIENT WAS CONSCIOUS, BUT RETURNED TO THE ICU FOR MONITORING. THE PATIENT'S CONDITION IMPROVED AT THIS POINT. NO ERROR MESSAGES ON EQUIPMENT DURING PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE. THE PHYSICIAN MENTIONED THAT RIGHT VENTRICULAR OUTFLOW TRACT, THE SITE OF ABLATION, IS NORMALLY INDENTED, BUT THE PATIENT'S RIGHT VENTRICULAR OUTFLOW TRACT WAS APPEARED EVEN MORE INDENTED THAN OTHERS ON THE COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT'S BREATH WAS DEEP, SO THE TIP OF THE CATHETER MAY HAVE BEEN STUCK IN THE INDENTED HOLLOW DURING ABLATION, RESULTING IN CARDIAC TAMPONADE. THE PATIENT BECAME STABLE AND MOVED TO GENERAL WARD ON THE DAY AFTER THE PROCEDU

  Patient problems: Cardiac Tamponade

  MAUDE report 18489530 ↗
• MalfunctionDec 12, 2023Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND AN IRRIGATION ISSUE OCCURRED. AN ERROR WAS DETECTED ON THE SMARTABLATE DUE TO A TEMPERATURE INCREASE, CAUSING THE APPLICATION TO CRASH. THE PATIENT'S EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER WAS REMOVED AND THE IRRIGATION WAS INCREASED TO 70. THEY FOUND THAT IT WAS CLOGGED AND WAS NOT IRRIGATING PROPERLY. SURGERY DELAYED 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THIS ISSUE WAS NOTED DURING THE DEVICE WAS USED ON THE PATIENT. THE ISSUE WAS DISCOVERED ON THE SMARTABLATE DUE TO TEMPERATURE INCREASE, CAUSING THE APPLICATION TO CRASH. THE PATIENT'S EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER WAS REMOVED AND THE IRRIGATION WAS INCREASED TO 70. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS NOT SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE TEMPERATURE INCREASE CAUSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314047 ↗
• InjuryDec 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) WHICH INCLUDED THE USE OF AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND EXPERIENCED HEART BLOCK REQUIRING IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) FOR AN INTERVENTION AND HOSPITALIZATION. THE EVENT OCCURRED WHEN THE SEPTUM OF LEFT VENTRICLE (LV) WAS ABLATED BY THERMOCOOL DURING VT IN THE MIDDLE OF THE PROCEDURE, AND WHEN THE VT WAS TERMINATED. THE PROCEDURE WAS CONTINUED AS IT WAS AND COMPLETED WITHOUT ANY PROBLEM. THE PATIENT STILL HAD THE LEFT BUNDLE BRANCH BLOCK WHEN LEAVING THE ROOM. THIS EVENT WAS INITIALLY ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 09-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS IMPLANTED IN THE PATIENT. THE PATIENT RECOVERED WITH NO DISABILITIES THAT INTERFERES WITH DAILY ACTIVITY AFTER AN EXTENDED HOSPITALIZATION. WITH THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT IS NOW CONSIDERED MDR REPORTABLE. THE AWARENESS DATE WAS 09-NOV-2023.

  Patient problems: Heart Block

  MAUDE report 18280662 ↗
• InjuryJun 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT AFTER COMPLETION OF THE PROCEDURE, POOR CARDIAC SHADOWING WAS SHOWED BY FLUOROSCOPY AND PERICARDIAL EFFUSION VOLUME WAS CONFIRMED BY ECHOCARDIOGRAPHY. BLOOD PRESSURE DROPPED TO THE 60S, BUT THE PATIENT WAS CLEARLY CONSCIOUS. TIMING WAS IMMEDIATELY AFTER COMPLETION OF THE PROCEDURE, BY THE ECHOCARDIOGRAPHY. PERICARDIAL DRAINAGE WAS PERFORMED, BLOOD PRESSURE WAS STABILIZED, AND THE PATIENT RETURNED TO INTENSIVE CARE UNIT (ICU). ATRIAL SEPTAL PUNCTURE WAS PERFORMED. SEPTAL PUNCTURE WAS PERFORMED WITH FUKUDA DENSHI RF NEEDLE AND ABLATION WAS CONDUCTED IN THE LEFT VENTRICLE. ABLATION WAS PERFORMED BEFORE THE CARDIAC TAMPONADE WAS DETECTED. STEAM POP WAS NOT CONFIRMED. IRRIGATION CATHETER WAS USED, THE FLOW RATE SETTING WAS PRE 1 SEC., POST 5 SEC. SETTING, IRRIGATION 17ML, HIGH FLOW 30ML, NO CHANGE AFTER THE PERICARDIAL DRAINAGE, THE BLOOD PRESSURE RETURNED TO THE 100S AND STABILIZED, AND CONSCIOUSNESS WAS CLEAR THROUGHOUT THE PROCEDURE. THE PATIENT WAS FOLL

  Patient problems: Cardiac Tamponade

  MAUDE report 17188089 ↗

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