EZ Steer NAV DS BN7TCDD8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835002980), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT ((B)(6)) UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH EZ STEER" NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC ARREST REQUIRING CPR, DEFIBRILLATOR AND MEDICATION. DURING AN ATRIAL FLUTTER RIGHT SIDED, ON (B)(6) 2021 AT APPROXIMATELY 1P THE PATIENT CODED. THE PATIENT DID NOT HAVE A PULSE AND IT WAS CONFIRMED BY THE RECORDING SYSTEM AND BY THE PHYSICIAN. THE PATIENT RECEIVED CPR AND MEDICATION (UNKNOWN TYPE) AND THE PULSE WAS RESTORED, AND THE BLOOD PRESSURE RESTORED TO NORMAL RANGE AS WELL. NO ABLATION HAD OCCURRED, AND THEY WERE PREFORMING ENTRAINMENT MAPPING WHEN THE ISSUE OCCURRED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE ADVERSE EVENT WAS DISCOVERED WHILE EZ STEER" NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS IN THE RIGHT ATRIUM (ABLATOR) AND CORONARY SINUS (WEBSTER ¿ CS CATHETER WITH EZ STEER" TECHNOLOGY). NO ABLATION HAD OCCURRED PRIOR TO THE EVENT. THE PHYSICIANS OPINION ON THE CAUSE OF THIS ADVERSE IS THAT THIS IS PATIENT CONDITION RELATED. THE EF WAS LOW TO BEGIN WITH, AND THE PHYSICIAN WAS NOT POSITIVE ON WHAT HAPPENED BUT REFERRED TO IT AS A TRANSIENT ASYSTOLE. CODE

  Patient problems: Cardiac Arrest

  MAUDE report 12391726 ↗