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Inquiry™ IBI-81683Recalls & reported problems

Irvine Biomedical, Inc. · Diagnostic Catheter · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734305297), received between Aug 6, 2018 and Nov 2, 2018 — classified as 3 injuries.

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 Problem3

Patient problems

  • Cardiac Perforation3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE: 3008452825-2018-00371, 3008452825-2018-00372, 3005334138-2018-00417. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, FOLLOWING A TRANSSEPTAL PUNCTURE, DURING GEOMETRY CREATION, A CARDIAC PERFORATION WAS NOTED. AN ECHOCARDIOGRAM CONFIRMED A PERFORATION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE LOCATION AND CAUSE OF THE PERFORATION IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

    Patient problems: Cardiac Perforation

    MAUDE report 8033397 ↗
  • InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE: 3005334138-2018-00336, 3008452825-2018-00329. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS FOLLOWED IN THE ICU. IT WAS INDICATED THE PERFORATION OCCURRED DURING ABLATION IN THE CORONARY SINUS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

    Patient problems: Cardiac Perforation

    MAUDE report 7920410 ↗
  • InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER NUMBER: 3005334138-2018-00242, 3008452825-2018-00265. AT THE END OF THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER ISOLATING THE VEINS 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 7755381 ↗

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.