LithoVueRecalls & reported problems across all models

We found 6 models of LithoVue by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2017 and Sep 21, 2026 — classified as 45 injuries, 94 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LithoVue problems

LithoVue models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LithoVue M0067913500

  Ureteroscope and accessories, flexible/rigid
  84 reports
• LithoVue M0067913600

  Ureteroscope and accessories, flexible/rigid
  29 reports
• LithoVue M0067917000

  Ureteroscope and accessories, flexible/rigid
  11 reports
• LithoVue M0067911000

  Ureteroscope and accessories, flexible/rigid
  7 reports
• LithoVue M0068010000

  Ureteroscope and accessories, flexible/rigid
  6 reports
• LithoVue M006801000R0

  Ureteroscope and accessories, flexible/rigid
  2 reports

Recent LithoVue adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 10, 2026No Display/Image

  It was reported that during the procedure, when the scope was connected no image displayed on the screen. The procedure was cancelled and rescheduled. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713511 ↗
• 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 ↗
• MalfunctionMay 6, 2026Positioning Problem

  DURING PROCEDURE, THE SCOPE UNDERGOES EXTREME DEFLECTION, THAT CAUSES THE DEFLECTION MECHANISM OF THE SCOPE FAILED. THE PROCEDURE WAS RESCHEDULED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095732 ↗
• MalfunctionApr 23, 2026

  PATIENT UNDERWENT A CYSTOSCOPY WITH URETERAL STENT EXCHANGE, URETEROSCOPY WITH HOLMIUM LITHOTRIPSY, RIGHT URETERAL STONE REMOVAL, RIGHT RENAL STONE REMOVAL, CYSTOLITHOLAPAXY WITH LASER. DURING THE PROCEDURE SURGEON REQUESTED TO UTILIZE A LITHOVUE DEVICE. AFTER PLUGGING IN THE DISPOSABLE IT FUNCTIONED APPROPRIATELY FOR APPROXIMATELY 30 SECONDS, BEFORE FAILING TO PRODUCE AN IMAGE. DEVICE WAS RESET AND USE ATTEMPTED AGAIN WITHOUT SUCCESS. A SECOND DISPOSABLE LITHOVUE WAS OBTAINED AND UTILIZED BY SURGEON WITHOUT ISSUE. THE MALFUNCTIONING DEVICE WAS REMOVED FROM FIELD AT END OF CASE AND PLACED IN A RED BAG ALONG WITH ITS ORIGINAL PACKAGING. REF: M0067913500, LOT: 40424407, EXP:01/15/2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965239 ↗
• MalfunctionMar 31, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A LITHOVUE TOUCH PC WAS USED DURING PREPARATION, AND THE MONITOR DID NOT TURN ON. THE PROCEDURE WAS NOT COMPLETED 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 24749908 ↗
• MalfunctionMar 13, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A LITHOVUE TOUCH PC WAS USED DURING THE PROCEDURE, AND THE MONITOR DID NOT TURN ON. THE PROCEDURE WAS NOT COMPLETED 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 24591458 ↗
• 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 ↗
• MalfunctionOct 29, 2025Break

  DURING THE PROCEDURE, THE DISPOSABLE SCOPE'S DEFLECTION TIP BROKE WHILE BEING USED WITH THE LASER. A NEW DISPOSABLE SCOPE WAS USED AND SWITCHED ON BUT COULD NOT BE USED BECAUSE THE BLUE LEVER WAS BROKEN. A THIRD SCOPE WAS THEN USED FOR THE CASE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412816 ↗
• MalfunctionSep 12, 2025Break

  DURING COMMON BILE DUCT EXPLORATION, SURGEON STATES NEEDING A NEW LITHOVUE. STATES "IT BROKE, WE NEED A NEW ONE". NEW SUPPLY OBTAINED. ITEM SAVED & SENT TO MATERIALS. NO HARM TO PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036893 ↗
• MalfunctionSep 10, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE LITHOVUE FLEXSCOPE STOPPED DEFLECTING AND THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012768 ↗
• MalfunctionAug 20, 2025Mechanical Problem

  THE URETEROSCOPE'S TRIGGER STOPPED WORKING WHILE IN USE. THE TRIGGER PORTION REMAINED OUTSIDE OF THE PATIENT WHILE THE SCOPE WAS IN USE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848807 ↗
• MalfunctionJul 31, 2025No Display/Image; Device Displays Incorrect Message; Communication or Transmission Problem; No Display/Image; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, LITHOVUE SCOPE HAD A "HARDWARE MALFUNCTION" USER MESSAGE APPEARED ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683329 ↗
• MalfunctionJun 13, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION OF A URETEROSCOPY PROCEDURE, THE SEAL OF THE SCOPE WAS COMPROMISED. ANOTHER LITHOVUE SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON JUNE 30, 2025: IT WAS LATER CLARIFIED THAT THE SEAL WAS NOT DAMAGED PRIOR TO RECEIVING THE DEVICE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THAT THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE DEVICE IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208014 ↗
• MalfunctionMar 21, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THE LITHOVUE FLEXSCOPE DEFLECTION BROKE, IT COULD NOT BE STRAIGHTENED OUT AND HAD TROUBLE IN REMOVING THE SCOPE. IT WAS NOT KNOWN HOW THE SCOPE WAS REMOVED BUT AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665570 ↗

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