LithoVue M0068010000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729974789), received between May 27, 2021 and Sep 21, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847390 ↗
• MalfunctionMay 15, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING PREPARATION, THE SWITCH ON THE SCREEN OF THE TOUCH PC (B)(4) WILL NOT WORK. THE PROCEDURE WAS RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. 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 25191453 ↗
• MalfunctionJan 18, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE LITHOVUE CAPITAL WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SCOPE WAS PLUGGED IN, AND NO IMAGE APPEARED ON THE MONITOR EVEN DEMO SCOPES. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535930 ↗
• MalfunctionAug 11, 2022No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS USED IN A FURSL PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LITHOVUE TOUCH PC SHOWED HARDWARE ERROR USER MESSAGE ON THE SCREEN. 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 15211167 ↗
• MalfunctionJun 28, 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 ATTEMPTED TO BE USED ON (B)(6) 2021. TOUCH PC COULD NOT POWER ON, TRIED DIFFERENT SOCKET AND STILL WOULD NOT POWER ON. 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 12077039 ↗
• MalfunctionMay 27, 2021No 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 ON (B)(6) 2021. DURING PREPARATION, THE MONITOR WAS NOT SHOWING ANY IMAGE. THE SCREEN ONLY SHOWED A BLACK SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11897639 ↗