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Inquiry™ IBI-81207Recalls & 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 05414734303477), received between Jul 14, 2023 and Jul 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1
  • Signal Artifact/Noise1

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.

  • MalfunctionJul 14, 2023Signal Artifact/Noise; Material Deformation; Signal Artifact/Noise; Material Deformation

    DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A DISPLACED ELECTRODE WAS NOTED. WHILE IN THE RIGHT ATRIUM, THERE WAS NO SIGNAL NOTED ON THE EP SYSTEM. UPON INSPECTION OF THE CATHETER, IT WAS NOTED THAT THE ELECTRODES WERE NOT CORRECTLY ARRANGED AND THE SPACING WAS NOT CORRECT. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17325694 ↗

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.