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Inquiry™ IBI-81918Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734306201), received between Sep 24, 2022 and Sep 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 24, 2022Fracture; Fracture

    DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, WHEN ATTEMPTING TO LOCATE AN ELECTRODE IN THE CORONARY SINUS, IT WAS NOTED THAT DAMAGE WAS FOUND ON THE DISTAL END OF THE ELECTRODE. A CRACK WAS FOUND ON THE MOBILE ELECTRODE DEFLECTION POINT. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15476504 ↗

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.