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Inquiry™ IBI-81680Recalls & reported problems

Irvine Biomedical, Inc. · 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 05414734305273), received between Oct 29, 2018 and Oct 29, 2018 — 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
  • Vascular Dissection1

Recent adverse event reports

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

  • InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A DISSECTION OCCURRED RESULTING IN A CARDIAC TAMPONADE.  WHILE CREATING GEOMETRY, THE USER NOTED DIFFICULTY MANEUVERING THE CATHETER DUE TO THE PATIENT'S ANATOMY IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) THE PATIENT BECAME HYPOTENSIVE. THE ABLATION PROCEDURE WAS STOPPED AND THE PATIENT WAS TRANSFERRED TO OPEN HEART SURGERY TO REPAIR THE VESSEL DISSECTION. UPON REMOVAL THE CATHETER OPERATED AS EXPECTED AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. THE PATIENT IS STABLE.

    Patient problems: Cardiac Perforation; Vascular Dissection

    MAUDE report 8016012 ↗

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.