EZ Steer NAV BN7TCJJ4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835003055), received between Nov 9, 2020 and Aug 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P990025); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. IT WAS REPORTED THAT THE PHYSICIAN ACCIDENTALLY BURNED THE AV (ATRIOVENTRICULAR) NODE AND THE PATIENT LOST CONDUCTION AND WAS IN COMPLETE HEART BLOCK. THE NGEN FOOT PEDAL WAS USED TO APPLY ABLATION DURING THE PROCEDURE AND THAT THE PHYSICIAN ACCIDENTALLY HIT THE NGEN FOOT PEDAL AFTER THE PATIENT WAS IN HEART BLOCK. THE LOSS OF CONDUCTION WAS NOTICED AND CONFIRMED ON THE INTRACARDIAC SIGNALS DISPLAYED ON THE CARTO 3 SYSTEM. THE PROCEDURE WAS ABORTED. NO MEDICAL INTERVENTION HAD BEEN PERFORMED. THE PHYSICIAN HAD SET UP FOR A PACEMAKER AND THAT THE PATIENT WAS ADVISED THAT THE PATIENT WOULD RECEIVE A PACEMAKER HOWEVER IT WAS REPORTED THAT THE CONDUCTION WAS SLOWLY RECOVERING AND COMING BACK BUT NOT FULLY. THE PATIENT WAS MOVED TO THE POST-OP AREA TO BE MONITORED AND THAT IT WOULD BE DETERMINED AT A LATER TIME IF THE PATIENT WOULD NEED A PACEMAKER. HOWEVER IT WAS REPORTED THAT THE PATIENT HAD FULLY RECOVERED AND DID NOT NEED A DEVICE. THE PHYSICIAN'S OPINION ON THE CAUSE

  Patient problems: Heart Block

  MAUDE report 22806993 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6), 83KG) WITH 1ST DEGREE ATRIOVENTRICULAR (A/V) BLOCK PRIOR TO THE START OF THE PROCEDURE, UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A COMPLETE HEART BLOCK REQUIRING PACEMAKER IMPLANTATION. THE EVENT OCCURRED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE CATHETER POSITION MOVED POSTERIORLY WHILE ABLATION WAS BEING APPLIED. THE CATHETER WAS IN THIS POSITION FOR LESS THAN 2 SECONDS WHEN THE ENERGY APPLICATION WAS STOPPED. THE PHYSICIAN¿S OPINION IS THAT THE CAUSE OF THE EVENT IS PROCEDURE. MAX WATTAGE USED FOR THE ENTIRE PROCEDURE WAS 35 WATTS. A TEMPORARY PACING LEAD WAS PLACED, AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION. THE PATIENT CONDITION IS UNCHANGED. EXTENDED HOSPITALIZATION WAS REQUIRED, THE PATIENT HAD A PERMANENT PACEMAKER IMPLANTED THE FOLLOWING DAY AND WAS DISCHARGED TO HOME.

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 10814595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990025. One submission often covers many models, so check the product and lot details in each record.

• Z-0369-2010 · Oct 2, 2008 · Terminated
  Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02