EZ Steer NAV BN7TCFF4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835003017), received between Feb 6, 2019 and Jun 9, 2020 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT NODAL TACHYCARDIA (AVRNT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE. AT AN UNSPECIFIED POINT, THE PATIENT DEVELOPED A CARDIAC TAMPONADE. IT IS UNKNOWN AT THIS TIME HOW IT WAS DISCOVERED AND WHAT TYPE OF MEDICAL INTERVENTION WAS PROVIDED. THERE¿S NO INDICATION THAT EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PHYSICIAN¿S CAUSALITY OPINION WAS NOT PROVIDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 10132967 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE ON THE FREE WALL OF THE RIGHT VENTRICLE (RV), CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED IN STABLE CONDITION AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME IS IMPROVED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO THE BIOSENSE WEBSTER, INC. PRODUCT MANIPULATION. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED DURING THE CASE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE IMPEDANCE JUMPED HIGH AND ABLATION WAS CUT OFF BY THE GENERATOR. THE VISITAG MODULE WAS USED AND THE PARAMETERS FOR STABILITY WERE 2 MM FOR 5 SECONDS, 40% 5G, TAG SIZE 2. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG MODULE. THE COLOR OPTION USED PROSPECTIVELY WAS IMPEDANCE DROP

  Patient problems: Cardiac Tamponade

  MAUDE report 8689086 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK AV REQUIRING PACEMAKER IMPLANTATION. DURING THE PROCEDURE, THE PATIENT WENT INTO HEART BLOCK AV. A TEMPORARY PACEMAKER WAS IMPLANTED. NO FURTHER INTERVENTION WAS REQUIRED. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT¿S OUTCOME. THERE WERE NO ERROR MESSAGES NOTED ON THE EQUIPMENTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 8312508 ↗

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