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Inquiry™ IBI-81734Recalls & reported problems

Irvine Biomedical, Inc. · 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 05414734305662), received between Aug 8, 2019 and Aug 8, 2019 — 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.

  • InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURING REF: 3008452825-2019-00366, 3008452825-2019-00368, 3008452825-2019-00369, 3008452825-2019-00370, 3005334138-2019-00438. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. DURING MANIPULATION IN THE LEFT ATRIUM AND PULMONARY VEINS, THE PATIENT EXPERIENCED CHEST PAIN, DECOMPRESSION SICKNESS AND THEIR BLOOD PRESSURE DROPPED. A CARDIAC ECHO CONFIRMED A BLOOD LEAK TO THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. MEDICATION WAS ADMINISTERED TO INCREASE BLOOD PRESSURE AND THE PATIENT WAS DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Patient problems: Cardiac Perforation

    MAUDE report 8876453 ↗

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.