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Inquiry™ IBI-81174Recalls & reported problems

Irvine Biomedical, Inc. · Class 2

Adverse event reports
7
Deaths reported
1
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734303361), received between Jun 11, 2019 and Oct 26, 2020 — classified as 1 death, 6 injuries.

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

  • Adverse Event Without Identified Device or Use Problem6
  • Material Deformation1

Patient problems

  • Cardiac Perforation5
  • Death1
  • Tissue Damage1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURING REF: 3008452825-2020-00581, 3005334138-2020-00528, 3005334138-2020-00529, 3008452825-2020-00582. AT THE END OF THE ATRIAL FIBRILLATION ABLATION PROCEDURE, AN ECHOGRAPHY REVEALED A PERICARDIAL EFFUSION. IT WAS NON EVOLUTIVE AND THE PATIENT LEFT THE LAB WITHOUT ANY INTERVENTION. THE FOLLOWING DAY, A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Patient problems: Cardiac Perforation

    MAUDE report 10733762 ↗
  • InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00308, 2182269-2020-00059, 3008452825-2020-00309. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED, AND GEOMETRY WAS BEING COLLECTED, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 10275394 ↗
  • InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE: 3008452825-2020-00281, 3008452825-2020-00282, 3005334138-2020-00227, 3008452825-2020-00283, 3005334138-2020-00228. DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC EFFUSION OCCURRED. FOLLOWING THE PROCEDURE, THE PATIENT HAD NO SYMPTOMS, HOWEVER AN ECHOCARDIOGRAM CONFIRMED THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE LOCATION AND CAUSE OF THE EFFUSION REMAINS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 10140500 ↗
  • InjuryMar 25, 2020Material Deformation; Material Deformation

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, CONFIRMING TISSUE ON THE RETURNED DEVICE.

    Patient problems: Tissue Damage

    MAUDE report 9880390 ↗
  • DeathMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE: 3008452825-2020-00126, 3005334138-2020-00078, 2182269-2020-00024, 3005334138-2020-00079, 3008452825-2020-00127. DURING A LEFT ATRIAL FLUTTER ABLATION, A POSSIBLE STROKE AND SUBSEQUENT DEATH OCCURRED. IT WAS INDICATED THE CAUSE OF DEATH MAY HAVE BEEN A STROKE. THE ABLATION ITSELF WAS NOT THE ALLEGED CAUSE OF DEATH, HOWEVER, THE CAUSE IS UNKNOWN. THE DEATH OCCURRED 72 HOURS FOLLOWING THE ABLATION PROCEDURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Death

    MAUDE report 9820054 ↗
  • InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2019-00568, 3008452825-2019-00510, 2182269-2019-00179, 2182269-2019-00180, 3008452825-2019-00512. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AS GEOMETRY WAS BEING COLLECTED THE PATIENT BECAME HYPOTENSIVE. A ECHOCARDIOGRAM WAS PERFORMED, REVEALING THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 9245217 ↗
  • InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURING REF: 3008452825-2019-00275, 3008452825-2019-00274, 3008452825-2019-00273. FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. IN THE RECOVERY ROOM, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 8686983 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.