Inquiry™ IBI-81947Recalls & reported problems
Irvine Biomedical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734306362), received between Jan 25, 2019 and Jan 25, 2019 — classified as 1 death.
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
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURING REFERENCE: 3008452825-2019-00022, 3005334138-2019-00028, 3005334138-2019-00029, 3005334138-2019-00030, 2182269-2019-00007. FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPIRED. DURING THE PROCEDURE, THE SEPTUM FELT HARD (NON-ELASTIC), FIBROTIC AND RESISTANT DUE TO A PREVIOUS PROCEDURE. DURING POST PROCEDURE HOSPITALIZATION, A PERICARDIAL EFFUSION WAS DISCOVERED WHICH EVOLVED INTO CARDIAC ARREST DURING THE NIGHT. REANIMATION WITH CARDIAC MASSAGE WAS PERFORMED, HOWEVER THE EFFECT OF THE CARDIAC ARREST LED TO CEREBRAL DEATH EIGHT DAYS POST PROCEDURE AND THE PATIENT EXPIRED ON (B)(6) 2019. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.
Patient problems: Death
MAUDE report 8276887 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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