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Inquiry™ IBI-81202Recalls & reported problems

Irvine Biomedical, Inc. · 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 05414734303439), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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

  • Device Damaged by Another Device1
  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 2, 2018Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING DISPLACED ELECTRODES ON THE CATHETER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8035137 ↗

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.