LithoVue M0067911000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729874522), received between Sep 10, 2020 and Feb 20, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Failure to Power Up

  IT WAS REPORTED DURING THE URETEROSCOPIC PROCEDURE, IT WAS NOTED THAT THE UNIT WON'T TURN ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399922 ↗
• MalfunctionJul 25, 2024No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PREPARATION, TWO LITHOVUE FLEXSCOPES WERE USED AND PLUGGED INTO THE MONITOR AND "HARDWARE MALFUNCTION" USER MESSAGE KEPT ON APPEARING ON THE MONITOR SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833788 ↗
• MalfunctionNov 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE CAPITAL WAS INTENDED TO BE USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2022. DURING PROCEDURE, THE LITHOVUE CAPITAL POWER ADAPTER WAS HAVING ISSUES AND WENT OUT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753824 ↗
• MalfunctionMay 27, 2022No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2022-02815 FOR THE LITHOVUE CAPITAL AND MFR. REPORT # 3005099803-2022-02816 FOR THE LITHOVUE FLEXSCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE CAPITAL AND A LITHOVUE FLEXSCOPE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A USER MESSAGE APPEARED ON THE SCREEN WHEN THE FLEXSCOPE WAS CONNECTED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO REPORTED SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522207 ↗
• MalfunctionFeb 17, 2022No Display/Image; No Display/Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE SCOPE WAS ATTEMPTED TO BE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE SCOPE WAS PLUGGED INTO THE LITHOVUE WORKSTATION AND NO IMAGE APPEARED. ANOTHER SCOPE WAS OPENED TO TEST IF THIS WAS AN ISSUE WITH THE WORK STATION AND THEM SAME THING HAPPENED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548684 ↗
• MalfunctionJan 5, 2021Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE TOUCH PC WAS USED AND THERE WAS NO IMAGE ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

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

  MAUDE report 11118054 ↗
• MalfunctionSep 10, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS USED DURING A KIDNEY STONE TREATMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE FLEXSCOPE WAS CONNECTED TO THE MONITOR AND A HARDWARE MALFUNCTION ERROR AS WELL AS SCOPE DISCONNECTED ERROR OCCURRED. THE MONITOR WAS UNPLUGGED AND PLUGGED BACK IN HOWEVER IT DID NOT RESOLVE THE ISSUE. A SECOND LITHOVUE FLEXSCOPE WAS OPENED AND THE SAME ISSUE OCCURRED. THE LITHOVUE SCOPES WERE TESTED WITH ANOTHER LITHOVUE MONITOR AND WORKED FINE THEREFORE IT WAS DETERMINED THE ISSUE WAS WITH THE TOUCH PC. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10514880 ↗