EZ Steer NAV DSRecalls & reported problems across all models

We found 3 models of EZ Steer NAV DS by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2016 and Feb 20, 2026 — classified as 13 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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 NAV DS problems

EZ Steer NAV DS models

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

• EZ Steer NAV DS BN7TCDF8L

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  17 reports
• EZ Steer NAV DS BN7TCFJ8L

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  15 reports
• EZ Steer NAV DS BN7TCDD8L

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 report

Recent EZ Steer NAV DS adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionFeb 3, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH AN EZ STEER NAV DS CATHETER AND OBSERVED AN ELECTRODE WITH LIFTED OR SHARP RINGS. NOTICED DURING INITIAL TEST, THE TIP OF THE CATHETER AND ELECTRODES COMPRESSED. CATHETER WAS REPLACED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 12-JAN-2026. THERE WAS PHYSICAL DAMAGE ON THE TIP. DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID RESULT IN LIFTED OR SHARP RINGS. THE DEVICE WAS NOT PRE-SHAPED. THE INITIALLY REPORTED ¿TIP OF THE CATHETER AND ELECTRODES COMPRESSED¿ EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 12-JAN-2026 THAT THE DAMAGE RESULTED IN LIFTED OR SHARP RINGS AND HAVE ASSESSED THE ELECTRODE WITH LIFTED OR SHARP RINGS ISSUE AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 12-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254830 ↗
• 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 ↗
• MalfunctionAug 12, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A EZ STEER NAV DS WHICH HAD DEFLECTION STUCK. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE EZ STEER NAV DS HAD A DEFLECTION ISSUE DURING THE PROCEDURE. THE CALLER STATED THE D CURVE WAS NOT WORKING. THE CALLER STATED THE CATHETER WOULD NOT DEFLECT. THE CALLER STATED THE CATHETER WAS REMOVED FORM THE BODY AND THE TIP WAS STRAIGHTENED OUT. THE PROCEDURE CONTINUED. THE CALLER STATED THE PHYSICIAN OPTED OUT OF REPLACING THE CATHETER. THE CUSTOMER'S REPORTED DEFLECTION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 5-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CATHETER WAS ACTUALLY STUCK IN A PARTIAL DEFLECTION. CATHETER COULD NOT DO THE F CURVE. THERE WAS NO DIFFICULTY WITHDRAWING THE CATHETER AND NO DAMAGE TO ANY ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790313 ↗
• MalfunctionJul 28, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT-SIDED ATRIAL FLUTTER ABLATION PROCEDURE WITH A EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE, THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN TIP WITH EXPOSED WIRING. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE DEFLECTION WAS NOT ADEQUATE AND THE CATHETER WAS NOT MANEUVERING APPROPRIATELY. THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE CATHETER HAD A KINK IN THE SHAFT. THE CATHETER WAS REPLACED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628592 ↗
• MalfunctionOct 9, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TYPICAL FLUTTER ABLATION PROCEDURE WITH AN EZ STEER NAV DS FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SMALL CRACK NEAR THE SECOND RING. DURING THE PROCEDURE, THERE WAS AN ISSUE ON THE DEFLECTION OF THE TIP OF THE ABLATION CATHETER. THE CATHETER DID NOT BEND PROPERLY. ANOTHER CATHETER WAS USED IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. LENGTHENING OF PROCEDURE TIME WAS OF APPROXIMATELY 3 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 18-SEP-2024 OBSERVED IT BENT AND SMALL CRACK NEAR THE SECOND RING. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE SMALL CRACK NEAR THE SECOND RING ON 18-SEP-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407292 ↗
• 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 ↗
• MalfunctionOct 26, 2023

  NOISY SIGNALS ON ABLATION CATHETER THAT HAD ENTERED THE PATIENT'S BODY. CABLE FOR ABLATION CATH EXCHANGES X2 WITH NO CHANGE. NO HARM DONE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010970 ↗
• MalfunctionSep 21, 2023Material Separation; Positioning Problem; Material Separation; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER - RIGHT ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PHYSICIAN STATED THAT THE CATHETER WAS NO LONGER DEFLECTING AND WAS NOT GETTING GREAT CONTACT. THE DEVICE WAS "VISUALLY BROKEN", WHICH THE PHYSICIAN CONFIRMED TO MEAN THAT THE CATHETER WAS BENT AT THE TIP. THE DAMAGE WAS DONE AT THE VERY DISTAL PORTION OF THE CATHETER. THERE WERE NO EXPOSED WIRES, LIFTED RINGS, OR SHARPENED RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NO PRE-SHAPED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791155 ↗
• 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 ↗
• MalfunctionMar 3, 2022Signal Artifact/Noise; Communication or Transmission Problem

  CATHETER INSERTED AND ALL ELECTRODES WENT BLACK DURING ABLATION. NO INFORMATION WAS TRANSMITTABLE TO CARTO ((01) (B)(4)). NEW CATHETER UTILIZED AND ISSUE RESOLVED. NO ADVERSE HARM TO PATIENT. REP CALLED IN PRODUCT. CATHETER INSERTED, BAD ELECTRODE, NOISY SIGNAL (01)(B)(4). NO ADVERSE HARM TO PT. NEW CATHETER UTILIZED W/O ISSUES. REP CALLED IN PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659025 ↗
• InjuryDec 10, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6) KGS) UNDERWENT AN ATRIAL FIBRILLATION (AFIB)/ ATRIAL FLUTTER (AFLUTTER) ABLATION PROCEDURE WITH A (B)(6) NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT WHILE ABLATING THE CAVO-TRICUSPID ISTHMUS (CTI) LINE, THE PHYSICIAN HEARD A STEAM POP AND IT WAS NOTICED THE PATIENT HAD PERICARDIAL EFFUSION. THE EFFUSION WAS CONFIRMED VIA THE PATIENT'S BLOOD PRESSURE DECLINING AND VIA THE ICE CATHETER. A PERICARDIOCENTESIS WAS DONE AND 970 CCS OF FLUID WERE REMOVED. THE PATIENT IS GOING TO THE OPERATING ROOM (OR) FOR SURGICAL REPAIR. THE PATIENT WAS NOT STABLE WHEN THEY LEFT THE ROOM FOR THE OR AND THE REPORTER HEARD THAT WHEN THE PATIENT ARRIVED IN THE OR THEIR BLOOD PRESSURE DROPPED AGAIN. THE REPORTER DID NOT SPEAK TO THE PHYSICIAN. THE REPORTER STATED THEY WERE USING AN 8 MM "DF" CURVE ABLATION CATHETER, BWI CS CATHETER, ACCUNAVE CATHETER, AND CRYO SHEATH. THE ABLATION CATHETER DID NOT GO INTO THE LEFT SIDE OF THE HEART ONLY THE CYRO. THE SMARTABLATE GENERATOR WAS SET FOR 70 WATTS AND 60 DEGREES, BUT THEY THINK THEY ONLY USED 65 WATTS. ADDITIONAL

  Patient problems: Cardiac Tamponade

  MAUDE report 12974554 ↗

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