LithoVue™ Elite M0067940000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729997337), received between Apr 26, 2024 and Jun 5, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

• MalfunctionJun 5, 2026

  DURING PROCEDURE TEAM ATTEMPTED TO USE THE LITHOVUE ELITE -SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE. SENSOR FOR WATER PRESSURE STOPPED WORKING MID CASE. COULD NOT BE CORRECTED. SCOPE AND BOX SAVED. BOSTON SCIENTIFIC: REF# M006794000, LOT# 37817017, EXP:10/28/26. GTIN# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 25407882 ↗
• MalfunctionApr 1, 2026Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A LITHOVUE ELITE FLEXSCOPE WAS USED ON (B)(6) 2026 FOR A LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, ALTHOUGH THERE WAS NO REPORTED MALFUNCTION WITH THE FUNCTIONALITY OF THE SCOPE, IT WAS ALREADY CONTAMINATED UPON OPENING THE PACKAGE. A DIFFERENT TYPE OF SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760575 ↗
• MalfunctionJan 9, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE LITHOVUE ELITE FLEXSCOPE WAS LOCKED IN A DEFLECTED STATE INSIDE THE KIDNEY AND THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111895 ↗
• MalfunctionNov 20, 2024Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734451 ↗
• MalfunctionSep 3, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING THE PROCEDURE, THE DISTAL TIP COULD NO LONGER BE DEFLECTED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127590 ↗
• MalfunctionMay 1, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE ELITE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS A PUNCTURE IN THE BOX AND IN THE PACKAGING AND THE SEAL WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226214 ↗
• MalfunctionApr 26, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE ELITE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A TEAR WAS DISCOVERED IN THE PACKAGING AND THE SEAL WAS COMPROMISED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193308 ↗