EZ Steer NAV DS BN7TCFJ8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10846835003048), received between Jul 24, 2016 and Feb 20, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (4 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, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A EZ STEER NAV DS AND THE CATHETER TIP WAS BROKEN. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398559 ↗
• InjuryOct 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER NAV DS CATHETER, THE AV NODE WAS ABLATED DURING A CAVOTRICUSPID ISTHMUS (CTI) ABLATION. THE PATIENT SUBSEQUENTLY REQUIRED A PACEMAKER AND EXTENDED HOSPITALIZATION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS IATROGENIC AV-NODE ABLATION. THE INTERVENTION PROVIDED WAS CTI. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF PACEMAKER IMPLANTATION.

  Patient problems: Heart Block

  MAUDE report 23430216 ↗
• MalfunctionSep 16, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A EZ STEER NAV DS AND SOME OF THE BLUE COATING STRETCHED OUT AND THE WIRING WAS EXPOSED WHEN THE CATHETER WAS TAKEN OUT OF THE BODY. IT WAS BETWEEN THE DISTAL AND PROXIMAL ELECTRODES OF THE CATHETER. THERE WERE NO LIFTED NOR SHARP RINGS. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE OR DIFFICULTY. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231155 ↗
• MalfunctionAug 8, 2024Signal Artifact/Noise; Break; Electrical Shorting; Signal Artifact/Noise; Break; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A EZ STEER NAV DS AND AN ERROR OF ¿CURRENT LEAKAGE - DEVICE DISRUPTION ERROR #7 ¿ LEAKAGE¿ WAS DISPLAYED ON THE CARTO® 3 SYSTEM. THEY ALSO NOTICED THAT THE TIP OF THE CATHETER WAS BROKEN THROUGH THE FLUORO VIEW AND HAD TO REPLACE THE CATHETER. THE CATHETER WAS PULLED OUT OF THE BODY AND WAS CONFIRMED PHYSICALLY THE TIP WAS BROKEN. THE CATHETER WAS REPLACED WITH A THERMOCOOL SMARTTOUCH® SF CATHETER, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE "CURRENT LEAKAGE ERROR" WAS ACCOMPANIED BY A SIGNAL NOISE. SURFACE LEADS WERE NOT AFFECTED. DURING THE SIGNAL INTERFERENCE, THE AFFECTED CATHETER WAS INSIDE THE PATIENT¿S BODY. THE PHYSICIAN DID NOT HAVE DIFFICULTY REMOVING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945176 ↗
• MalfunctionAug 1, 2024Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A EZ STEER NAV DS AND THE CATHETER APPEARED BENT UNDER FLOUROSCOPY. THE PHYSICIAN REMOVED IT AND CONFIRMED THAT IT WAS BENT AT THE TIP. THEY REPLACED IT TO CONTINUE THE CASE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ON 17-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WAS A SMALL PART OF THE WIRE THAT WAS EXPOSED. WITH THE ADDITIONAL INFORMATION, THE EVENT IS NOW CONSIDERED MDR REPORTABLE WITH AN AWARENESS DATE OF 17-JUL-2024. THERE WERE NO RESISTANCE NOR DIFFICULTY DURING INSERTION AND REMOVAL. IT WAS NOTICED ON FLUORO THAT THE TIP WAS NOT STRAIGHT AFTER A FEW LESIONS HAD BEEN PLACED AND THEN REMOVED. THE DAMAGE WAS DISTAL TO THE PROXIMAL ELECTRODES. THE CATHETER WAS NOT PRE-SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19889177 ↗
• InjuryFeb 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV NODE ABLATION WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER (LOT NUMBER UNKNOWN) AND THE PATIENT EXPERIENCED PULMONARY EDEMA AND CARDIAC ARREST THAT REQUIRED CPR, INTUBATION, AND HOSPITALIZATION. FIRST, IT WAS REPORTED THAT THE CARTO 3 SYSTEM WAS DISPLAYING NOISE ON THE DISTAL ECG OF THE EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER (LOT NUMBER 30961886M) WHEN CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THE NOISE WAS ALSO SEEN ON THE RECORDING SYSTEM. THE ELECTRODE WAS BLACK ON THE CARTO 3 SYSTEM. THEY RESEATED THE CONNECTIONS WITH NO RESOLUTION. THEY REPLACED THE CABLE WITHOUT RESOLUTION. THE CATHETER WAS REPLACED WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER (LOT NUMBER UNKNOWN) AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. IT WAS ALSO REPORTED AFTER THE AV NODE ABLATION CASE, THE PATIENT SUFFERED A FLASH PULMONARY EDEMA. ANESTHESIA STARTED HAVING SOME ISSUES WITH THE PATIENT WHEN THEY NOTICED A DROP IN PULSE OX. THE PHYSICIAN WAS IN THE PROCESS OF REMOVING THE CATHETERS SO NO BIOSENSE WEBSTER, INC. (BWI) PRODUCTS WERE IN THE BODY AT THE TIME OF THE INJURY. ABOUT 3-

  Patient problems: Cardiac Arrest; Pulmonary Edema

  MAUDE report 18686627 ↗
• MalfunctionJan 6, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND AN ELECTRODE DAMAGED ISSUE OCCURRED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THE PHYSICIAN FELT THE CONTACT FORCE OF THE ABLATION CATHETER DID NOT FEEL RIGHT. THE ABLATION CATHETER WAS REMOVED FROM THE PATIENT AND INSPECTED. UPON INSPECTION, THEY SAW A DENT ON THE DISTAL ELECTRODE CLOSE TO THE TIP OF THE ABLATION CATHETER. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THERE WAS DIFFICULTY IN THE REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE PHYSICIAN STATED THAT THE CATHETER FELT DIFFERENT PHYSICALLY WHILE IN THE BODY. HE JUST STATED THAT IT FELT DIFFERENTLY WHEN HE SAW THAT IT WAS IN CONTACT WITH THE TISSUE ON FLUOROSCOPY. THEY EXCHANGED THE ABLATION CATHETER, AND THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE ELECTRODE DAMAGED ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110414 ↗
• MalfunctionFeb 19, 2021Output Problem

  INCIDENT DESCRIPTION: ABLATION CATHETER WAS NOT VISUALIZED ON CARTO. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347797 ↗
• MalfunctionJul 19, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER THAT WAS REPORTED TO HAVE A BROKEN TIP AFTER USE. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN PULLED THE CATHETER OUT THE INSULATION WAS SHOWING AT THE TIP OF THE EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND IT APPEARED TO BE BROKEN. THE ISSUE OF BROKEN TIP WITH INTERNAL COMPONENTS EXPOSED HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809578 ↗
• MalfunctionNov 16, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  A MALE PATIENT UNDERWENT A PROCEDURE WITH A EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WHEREIN PRE-OP, THE PACKAGING OF THE CATHETER WAS COMPROMISED. AT THE BEGINNING OF THE PROCEDURE WHEN THE PHYSICIAN ASKED TO GET THE CATHETER, WHEN THE PACKAGING WAS OPENED, THE DISTAL END OF THE PACKAGING AND THE CATHETER HANDLE FELL ON THE GROUND. STERILITY OF THE PRODUCT WAS COMPROMISED. THE PLASTIC PACKAGING WAS NOT ¿CLIPPED¿ CORRECTLY CAUSING THE CATHETER TO FALL. THE CATHETER WAS EXCHANGED, AND THEY CONTINUED WITH THE PROCEDURE. PRODUCT NEVER USED ON PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080281 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYOABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH AN EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, THE PATIENT WAS NOTICED TO HAVE A PERICARDIAL EFFUSION AND LOW BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FORM THE PERICARDIUM. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED FROM HOSPITAL. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE ADVERSE EVENT TO A BIOSENSE WEBSTER INC. (BWI) PRODUCT. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. IT IS UNKNOWN IF TRANSSEPTAL PUNCTURE WAS PERFORMED. THE PATIENT RECEIVED ANTICOAGULANT (UNSPECIFIED) DURING THE PROCEDURE. THE ACTIVATED CLOTTING TIME (ACT) WAS >600 SECONDS DURING THE CRYO PORTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPH

  Patient problems: Cardiac Tamponade

  MAUDE report 8003418 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH AN EZ STEER NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HYPOTENSION REQUIRING COMPUTED TOMOGRAPHY (CT) AND VASOPRESSORS. IMMEDIATELY POST-ABLATION, AFTER SUCCESSFUL TERMINATION OF ATRIAL FLUTTER, THE PATIENT BECAME HYPOTENSIVE. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS NEGATIVE FOR PERICARDIAL EFFUSION. PULMONARY ANGIOGRAPHY WAS NEGATIVE FOR PULMONARY EMBOLISM. ABDOMEN WAS DISTENDED, YET SUPPLE. CT WAS (B)(6) FOR RETROPERITONEAL BLEEDING AND PULMONARY EMBOLISM. PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) INTUBATED AND ON VASOPRESSORS. PATIENT REQUIRED EXTENDED (OVERNIGHT) HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. AT THE TIME OF COMPLAINT UPDATE, THE PATIENT WAS BEING WEANED FROM THE VENTILATOR IN PREPARATION FOR EXTUBATION. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MEDICAL HISTORY INCLUDES A PREVIOUS SURGICAL REPAIR OF AN ATRIAL SEPTAL DEFECT (ASD). PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO A SIGNIFICANT DECREASE IN CARDIAC OUTPUT SECONDARY TO TERMINATION OF LONG-TERM ATRIAL FLUTTER. IT WAS NOTED THAT THE

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7292411 ↗
• InjurySep 8, 2016No Display/Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH TWO (2) 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE SMARTABLATE GENERATOR WOULD NOT DISPLAY IMPEDANCE FOR THE TWO (2) 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS. THE CABLES WERE REPLACED, THE GENERATOR WAS RE-BOOTED, THE GENERATOR WAS EXCHANGED, AND PACE ROUTING WAS CONFIRMED TO BE DISABLED WITHOUT SUCCESS. THE 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS WERE EXCHANGED FOR A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER. THE SMARTABLATE GENERATOR INITIALLY DID NOT DISPLAY IMPEDANCE FOR THE SMARTTOUCH. THE CATHETER CONNECTOR WAS RE-SEATED INTO THE GENERATOR AND THE ISSUE WAS RESOLVED. DURING MAPPING WITH THE SMARTTOUCH CATHETER, THE PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 150-200CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 5938015 ↗
• InjurySep 8, 2016No Display/Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH TWO (2) 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE SMARTABLATE GENERATOR WOULD NOT DISPLAY IMPEDANCE FOR THE TWO (2) 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS. THE CABLES WERE REPLACED, THE GENERATOR WAS RE-BOOTED, THE GENERATOR WAS EXCHANGED, AND PACE ROUTING WAS CONFIRMED TO BE DISABLED WITHOUT SUCCESS. THE 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS WERE EXCHANGED FOR A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER. THE SMARTABLATE GENERATOR INITIALLY DID NOT DISPLAY IMPEDANCE FOR THE SMARTTOUCH. THE CATHETER CONNECTOR WAS RE-SEATED INTO THE GENERATOR AND THE ISSUE WAS RESOLVED. DURING MAPPING WITH THE SMARTTOUCH CATHETER, THE PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 150-200CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 5938003 ↗
• InjuryJul 24, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, IN HER (B)(6), UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH AN EZ STEER NAVIGATIONAL DS CATHETER AND SUFFERED HEART BLOCK AV THIRD DEGREE REQUIRING SURGICAL INTERVENTION (CARDIAC CATHETERIZATION WITH RIGHT CORONARY ARTERY STENT). DURING ABLATION, AFTER THE FIRST DRAG LESION WAS PERFORMED, THE ATRIAL FLUTTER BROKE AND SINUS RHYTHM WAS RESTORED. AFTER THE SECOND DRAG LESION WAS PERFORMED, THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. ECHOCARDIOGRAM CONFIRMED THAT THERE WAS NO PERICARDIAL EFFUSION. AT THIS POINT, THE PATIENT WAS IN COMPLETE HEART BLOCK AND THE PHYSICIAN BEGAN PACING WITH THE CATHETER. PATIENT WAS SENT TO THE CATH LAB FOR CARDIAC CATHETERIZATION AND A RIGHT CORONARY ARTERY STENT. AT THE TIME OF COMPLAINT REPORT, THE PATIENT HAD A TEMPORARY PACEMAKER AND A WIRE. IT WAS NOTED THAT THE EVENT WAS TEMPORARILY LIFE-THREATENING. THERE IS NO CONFIRMATION REGARDING EXTENDED HOSPITALIZATION, ALTHOUGH IT IS BELIEVED THAT THE PATIENT WAS KEPT IN THE HOSPITAL AFTER STENT PLACEMENT. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. IT WAS NOTED THAT THE PHYSICIAN WOULD HAVE LIKELY ASSESS

  Patient problems: Bradycardia; Complete Heart Block; Low Blood Pressure/ Hypotension; No Code Available; Pericardial Effusion

  MAUDE report 5818304 ↗