Stellaris BL14334Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00757770519996), received between Nov 22, 2024 and Jun 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED BY THE USER FACILITY IN MALAYSIA THAT THE SYSTEM WAS SHOWING VFM14 DURING THE PROCEDURE HOWEVER FLUID LEVEL IN CASSETTE WAS NOT FULL. WRONGLY DETECTED FLUIDIC LEVEL EVEN AFTER A NEW CASSETTE WAS INSERTED. THE FIELD SERVICE ENGINEER REPORTED THAT THE SYSTEM STOPPED UNINTENTIONALLY AFTER THE ERROR. THERE WAS A MINIMAL DELAY TO RESTART AND REINSERT THE CASSETTE. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292074 ↗
• MalfunctionNov 22, 2024Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN SLOVENIA REPORTED THAT DURING VITRECTOMY, THE INFUSION DID NOT FLOW. THE DEVICE DID NOT RECOGNIZE THE CASSETTE AND NOTICED THAT IT WAS FULL, HOWEVER, IT WAS NOT. TOWARDS THE END OF THE PROCEDURE, THE SYSTEM HAD SHUT DOWN. THERE WAS NO IMPACT OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762321 ↗