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EP XT™ M0042007940Recalls & reported problems

Boston Scientific Corporation · Unidirectional Steerable Diagnostic Catheter · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 08714729877547), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pericardial Effusion1

Recent adverse event reports

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

  • InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING A REDO ATRIAL FIBRILLATION PROCEDURE, AN EP-XT DIAGNOSTIC CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS, TRANSSEPTAL ACCESS, AND POSITIONED THE CATHETER. HE THEN PLACED THE AGILIS SHEATH, AND THEN LOOKED UP AT INTRACARDIAC ECHO, AND NOTICED A SMALL PERICARDIAL EFFUSION. THE PROCEDURE WAS CANCELLED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Pericardial Effusion

    MAUDE report 15997160 ↗

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

Sources and updates

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