LithoVue™ Elite M0067941000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729997351), received between Oct 20, 2025 and May 7, 2026 — classified as 1 injury, 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Optical Problem

  IT WAS REPORTED THAT DURING PROCEDURE, LITHOVUE ELITE SCOPE HAD A 3008-ERROR CODE APPEARED ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117977 ↗
• MalfunctionMay 7, 2026Optical Problem

  IT WAS REPORTED THAT DURING PROCEDURE, LITHOVUE ELITE SCOPE HAD A 3015-ERROR CODE APPEARED ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108895 ↗
• InjuryNov 18, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, DURING A FLEXIBLE URETEROSCOPY PROCEDURE, THE PHYSICIAN FOUND THAT THE LITHOVUE NON-PRESSURE URETEROSCOPE SHOWS PROBLEM WITH VISUAL. INITIAL OPTICS IN THE URETER WERE FINE; HOWEVER, ONCE THE SCOPE WAS DEFLECTED INTO THE KIDNEY AND A LASER FIBER WAS INTRODUCED, THE MONITOR BEGAN FLASHING BLACK AND WHITE IN A STROBE LIGHT. THE PROBLEM PERSISTED THROUGHOUT THE CASE. THE PHYSICIAN WAS UNABLE TO VISUALIZE THE KIDNEY STONE AND ABORTED THE PROCEDURE, PLACING A STENT INSTEAD. THE PATIENT IS EXPECTED TO FULLY RECOVER BUT WILL REQUIRE A SECOND SURGERY TO COMPLETE STONE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584555 ↗
• MalfunctionOct 30, 2025Defective Device; Connection Problem

  URETEROSCOPES WERE PULLED FOR AN URETEROSCOPY CASE. FOUR URETEROSCOPES WERE TRIED, BUT NONE OF THEM WORKED PROPERLY. THE SCOPES EITHER FAILED TO CONNECT, HAD FAULTY CHANNELS, OR DISPLAYED ERROR CODES. THE OPERATING ROOM TEAM COMMUNICATED DIRECTLY WITH THE REP, BUT THEY STILL COULDN'T GET THE SCOPES TO FUNCTION. IT WAS DECIDED TO PULL ALL URETEROSCOPES WITH THE SAME LOT NUMBERS. A TOTAL OF 3 MORE URETEROSCOPES WERE PULLED FROM THE SHELF. EMAIL COMMUNICATIONS CONTINUED WITH THE REP THRU THIS ENTIRE PROCESS. A TOTAL OF 7 SCOPES PROBLEMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424674 ↗
• MalfunctionOct 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE THE LITHOVUE ELITE FLEXSCOPE DIAMETER IS TOO LARGE FOR THE PATIENT'S URETER. THE PHYSICIAN PLACED A STENT, AND THE PROCEDURE WAS RESCHEDULED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341591 ↗