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EZ Steer BD7TCFJ4LRecalls & reported problems

Biosense Webster Inc · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835002584), received between Sep 6, 2022 and Sep 6, 2022 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • Heart Block1

Recent adverse event reports

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

  • InjurySep 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT A MALE PATIENT ((B)(6)1948) UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED HEART BLOCK REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT DURING AN AVNRT CASE, IT WAS NOTICED THAT THERE WAS COMPLETE HEART BLOCK IN THE PATIENT. THEY COULD NOT STOP THE ARRHYTHMIA, AND WHILE THE CATHETER WAS MOVING, THE IMPEDANCE WAS STABLE. WHEN THE PHYSICIAN DECIDED TO COME OFF ABLATION, IT WAS THEN NOTICED THAT THE PATIENT HAD COMPLETE HEART BLOCK ON THE RECORDING SYSTEM. THE PATIENT WAS THEN ADMINISTERED TWO DIFFERENT STEROIDS--THE SPECIFIC DOSAGE OR DRUG INFORMATION IS NOT AVAILABLE TO BWI. THE PATIENT HAD A TEMPORARY PACEMAKER IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DOES NOT BELIEVE THE COMPLETE HEART BLOCK WAS A RESULT OF ABLATION, RATHER THAT THE PATIENT HAD AV NODE CONDUCTION DISEASE. THE PHYSICIAN BELIEVES THAT THEY HAD ABLATED THE SLOW PATHWAY, BUT THAT THE PATIENT WAS "SICKLY" TO BEGIN WITH, AND THE PHYSICIAN BELIEVES IT'S POSSIBLE THAT THE PATIENT'S SLOW PATHWAY WAS THE ONLY PATHWAY THEY HAD LEFT. PATIENT OUTCOME

    Patient problems: Heart Block

    MAUDE report 15359168 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.