ILUMIEN™ C408650Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00183739000678), received between Dec 30, 2020 and May 11, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 11, 2023Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE MODERATELY STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE LET ANTERIOR DESCENDING ARTERY. THE LESION WAS EVALUATED AND RECORDED USING THE OPTIS SYSTEM AND DRAGONFLY CATHETER BEFORE TREATMENT. IT SHOWED A LESION LENGTH OF 38MM. THE PHYSICIAN CHECKED THE IMAGE OF ANGIO CO-REGISTRATION (ACR) AND SAID THE VALUE WAS WRONG. THE LESION LENGTH WAS EVALUATED AND RECORDED AGAIN, BUT THE SAME RESULT WAS NOTED. THE LESION WAS REMEASURED WITH QUANTITATIVE CORONARY ANGIOGRAPHY (QCA) AND IT MEASURED AT 33MM. A 3.5X33MM XIENCE STENT WAS SUCCESSFULLY IMPLANTED AT THE LESION. POST STENT IMPLANTATION, THE SYSTEM WAS MEASURED AND RECORDED, AND THE STENT LENGTH WAS MEASURED AT 37MM. IT WAS CONFIRMED THAT THE STENT DID NOT ELONGATE, IT WAS THE SYSTEM OPTIS SYSTEM GAVE THE INCORRECT MEASUREMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914733 ↗
• InjuryJan 14, 2021Failure to Power Up; Communication or Transmission Problem; Failure to Power Up; Communication or Transmission Problem

  DURING THE PROCEDURE, A CANCELLATION OCCURRED. THE PATIENT WAS IN-PATIENT OVERNIGHT FOR A PLANNED ANGIOGRAM AND OCT. AN ERROR MESSAGE APPEARED ON THE SYSTEM STATING "A SERIOUS ERROR HAS OCCURRED (111). THERE IS A PROBLEM COMMUNICATING WITH THE DOC. CLICK OK TO SHUT DOWN THE OCT SYSTEM." THE SYSTEM WAS RESTARTED AND ANOTHER ERROR MESSAGE APPEARED THAT STATED "CONFIGURATION ERROR (1337). INVALID HARDWARE CONFIGURATION. CONTACT YOUR AUTHORIZED SERVICE REPRESENTATIVE. DOC ERROR." THE ANGIOGRAM WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11174624 ↗
• InjuryDec 30, 2020Poor Quality Image; Communication or Transmission Problem; Poor Quality Image; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 2184149-2020-00241, 2184149-2020-00240. DURING THE PROCEDURE, A SIGNIFICANT DELAY OCCURRED. THE START UP OF THE SYSTEM WAS SIGNIFICANTLY PROLONGED AND "FFR RECEIVER FAULT DETECT" WAS DISPLAYED AFTER STARTUP. THE CONNECTION BETWEEN THE CATHETER AND THE DOC FAILED AND IT TOOK TWO TO THREE TIMES TO CONNECT SUCCESSFULLY. AFTER DETECTION THE IMAGING EFFECT WAS NOT GOOD, THE BRIGHTNESS AND CONTRAST WERE NOT HIGH, AND THE NATURE OF THE PLAQUE COULD NOT BE SEEN CLEARLY. THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM WITH NO ADVERSE PATIENT CONSEQUENCES. THE FFR RECEIVERS AND OPTICAL ADAPTER WERE REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11095630 ↗