ILUMIEN™ 900-700-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00183739000630), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Unexpected Shutdown” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 17, 2019Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE, THE IMAGING SYSTEM SCREEN WENT BLANK AND UPON REMOVAL OF THE CATHETER A THROMBUS WAS NOTED. THE CATHETER WAS IN THE RIGHT CORONARY ARTERY AND AFTER TWO RUNS, THE SCREEN WENT BLANK PRIOR TO THE CONTRAST BEING INJECTED. THE CATHETER WAS REMOVED AND THROMBUS WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANGIOGRAPHY WITH NO PATIENT CONSEQUENCES. AFTER THE PROCEDURE, THE SYSTEM WAS TESTED AND IT WAS NOTICED THAT IT WAS HARD TO START THE SYSTEM AND THE SCREENS WERE BLANK. THE OCT RUNS WERE NOT ALL CAPTURED ON THE SYSTEM. ALARMS AND BEEPING WAS HEARD COMING FROM THE SYSTEM.

  Patient problems: Thrombus

  MAUDE report 8797799 ↗