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Inquiry™ IBI-81938Recalls & reported problems

Irvine Biomedical, Inc. · Steerable Diagnostic Catheter · Class 2

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 05414734306294), received between Sep 29, 2020 and Sep 29, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiac Perforation1

Recent adverse event reports

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

  • InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING A CRT-D IMPLANT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER INSERTING THE CATHETER VIA LEFT SIDE ACCESS INTO THE CORONARY SINUS AND SUBSEQUENT IMAGING OF THE CONTRAST AGENT VIA X-RAY, A PERICARDIAL EFFUSION WAS IDENTIFIED IN THE CORONARY SINUS. THE CATHETER WAS RETRACTED BACK INTO THE SUPERIOR VENA CAVA. THE PERICARDIAL EFFUSION WAS MONITORED THROUGHOUT THE PROCEDURE AND THE IMPLANT DEVICE WAS PLACED SUCCESSFULLY AND THE PATIENT LEFT THE LAB IS IN STABLE CONDITION. THE PHYSICIAN BELIEVED THE CORONARY SINUS CATHETER MAY HAVE BEEN THE REASON FOR THE EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 10599286 ↗

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

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

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