EZ Steer NAV BN7TCDD4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835002973), received between May 24, 2019 and May 24, 2019 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING TESTING PHASE AFTER THE ABLATION, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 560 CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED, HE BELIEVED THE FRAIL CONDITION AS WELL AS THE SMALL SIZE AND PACING MANEUVERS PERFORMED WERE FACTORS THAT LED TO THIS ADVERSE EVENT. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED DURING THE CASE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. ERROR 255 WAS DISPLAYED ON THE CARTO SYSTEM; THE SYSTEM WAS ABLE TO COMPENSATE, AND ANOTHER MAP WAS PERFORMED TO ENSURE MAPPING POINTS. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR AND

  Patient problems: Cardiac Tamponade

  MAUDE report 8642483 ↗

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