Starlight Imaging Catheter 951Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00860008045508), received between May 9, 2025 and Aug 26, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Entrapment of Device

  "It was reported that a Starlight catheter was used for a coronary procedure . During use on the first delivery post stenting, the catheter was unable to cross the stent but was able to exit the guide catheter. On the second delivery, too much resistance was noted and the catheter would not exit the guide catheter. The physician decided not to proceed with imaging. No patient injury reported. This Product Problem is being submitted because the Starlight catheter and guide catheter were removed as a system. There is potential for harm if it were to recur."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452918 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  "It was reported that a Starlight catheter was used for a coronary procedure . During use, the catheter got kinked and could not be removed from the guide. A new catheter was used and able to cross. No patient injury reported. This Product Problem is being submitted because the Starlight catheter and guide were removed as a system. There is potential for harm if it were to recur.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452911 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452907 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452905 ↗
• InjuryAug 26, 2026Entrapment of Device

  "It was reported that a Starlight catheter was used for a coronary procedure. During use, red thrombus was seen inside the stent post PCI in the LAD, and treated by ballooning the thrombus to the wall and given integrilin bolus. The catheter had difficulty exiting the guide, and thought the catheter was going to kink. After several attempts, the angle of approach was changed, the catheter entered the vessel with trouble advancing into the PDA, but was able to eventually cross with some maneuvering of the guidewire. This Adverse Event is being submitted because the patient experienced thrombus, requiring additional intervention. There was no alleged malfunction reported with the Starlight catheter. "

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50452902 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452900 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452897 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452888 ↗
• MalfunctionAug 26, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452880 ↗
• MalfunctionJul 30, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090199 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT SUMMARY: A PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VFIB) DURING A CORONARY IMAGING PROCEDURE, SHORTLY AFTER A MANUAL SALINE INJECTION (USING A SYRINGE) WAS ADMINISTERED TO CLEAR THE VESSEL OF BLOOD. THIS INJECTION WAS A STANDARD CLINICAL STEP PERFORMED UNDER PHYSICIAN CONTROL AND DISCRETION TO PREPARE THE VESSEL PRIOR TO IMAGING. IN THIS CASE THE PHYSICIAN CHOSE TO USE THE HYPERVUE IMAGING SYSTEM & STARLIGHT CATHETER. THE SALINE FLUSH WAS NOT CONTROLLED OR DELIVERED BY THE DEVICE, AND NOT PERFORMED AUTOMATICALLY BY ANY DEVICE FUNCTION. THE PATIENT WAS DEFIBRILLATED WHICH STABILIZED PATIENT'S HEART RHYTHM. A SUBSEQUENT PULLBACK USING A CONTRAST INJECTION AS THE FLUSH MEDIUM WAS COMPLETED. DEVICE INVOLVEMENT ASSESSMENT: FOLLOWING IS BASED ON EVENT INFORMATION REPORTED AND INITIAL INVESTIGATION OF THE EVENT DETAILS. · WHEN THE DEVICE WAS USED IT FUNCTIONED PER SPECIFICATIONS AND DID NOT MALFUNCTION. · THE ADVERSE EVENT OCCURRED IN THE CONTEXT OF A PHYSICIAN-CONTROLLED STEP AND WAS NOT DUE TO ANY MALFUNCTION, IMPROPER USE, INADEQUATE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. · THE EVENT IS CONSIDERED RELATED TO THE PROCEDURE, NOT THE DEVICE. NOTE: USE OF SALINE OR CONT

  Patient problems: Ventricular Fibrillation

  MAUDE report 21998173 ↗