LithoVue M0067913500Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 08714729874805), received between Jan 3, 2017 and May 6, 2026 — classified as 40 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (10 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 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionDec 12, 2024

  PATIENT WAS BROUGHT TO THE OPERATING SUITE AFTER CONSENT WAS TAKEN. SHE WAS PLACED IN A DORSAL LITHOTOMY POSITION WHERE SHE WAS DRAPED AND PREPPED IN A STERILE FASHION. WHEN THE URETEROSCOPE WAS ATTACHED, THERE WAS NO PICTURE, NO LIGHT WITH THE SCREEN EMPTY. THE DEVICE WAS CHANGED FOR A NEW ONE AND THE PROCEDURE WAS DONE WITHOUT ANY FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID, LITHOVUE (PER SITE REPORTER). DEFECTIVE DEVICE REPORTED TO FIELD REPRESENTATIVE AND WOULD PICK IT UP IN THE OPERATING ROOM (O.R.) FROM SURGERY PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912674 ↗
• MalfunctionDec 9, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION, THE SEAL OF THE SCOPE WAS COMPROMISED. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877690 ↗
• MalfunctionNov 20, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION, THE SEAL OF THE SCOPE WAS COMPROMISED. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740320 ↗
• MalfunctionOct 9, 2024No Display/Image; Defective Device; No Display/Image; Defective Device

  IT WAS REPORTED THAT THE LITHOVUE FLEXSCOPE DID NOT WORK, AND THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412482 ↗
• MalfunctionSep 16, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE LITHOVUE FLEXSCOPE COULD ONLY ROTATE TO ONE SIDE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231459 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  IT WAS REPORTED DURING THE PROCEDURE, THE LENS OF THE SCOPE GOT SEPARATED AND WAS RETRIEVED USING A BASKET. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071044 ↗
• MalfunctionJul 23, 2024

  THE DISPOSABLE DIGITAL FLEXIBLE URETEROSCOPE DID NOT CONNECT TO MONITOR TO SHOW IMAGE WHEN PLUGGED IN. HAD TO WASTE ITEM AND OPEN A NEW ONE TO PLUG INTO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804421 ↗
• MalfunctionJul 10, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION, THE SEAL OF THE LITHOVUE FLEXSCOPE PACKAGE WAS FOUND TO BE BROKEN UPON OPENING. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716396 ↗
• MalfunctionJul 9, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION, THE SEAL OF THE LITHOVUE FLEXSCOPE PACKAGE WAS FOUND TO BE BROKEN UPON OPENING. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702791 ↗
• MalfunctionJun 13, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION, THE SEAL OF THE SCOPE PACKAGE WAS FOUND TO BE COMPROMISED. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533964 ↗
• MalfunctionJun 3, 2024Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ALITHOVUE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS A FOREIGN OBJECT FOUND ON THE KIDNEY OF THE PATIENT THAT CAME FROM THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448435 ↗
• MalfunctionMay 10, 2024Contamination; Contamination

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SCOPE GOT CONTAMINATED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294021 ↗
• MalfunctionMay 6, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, UPON OPENING THE PACKAGED, THE SCOPE WAS FOUND TO BE DIRTY ON THE HANDLE PART. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255481 ↗
• MalfunctionFeb 20, 2024Contamination; Contamination

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE SCOPE GOT CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOVUE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741020 ↗
• MalfunctionJan 19, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, A TEAR IN THE PACKAGING WAS NOTICED AND SEAL WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543999 ↗
• MalfunctionJan 18, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE PACKAGING WAS DAMAGED AND CONTAMINATED. SEAL WAS COMPROMISED. THE PROCEDURE COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540228 ↗