Single Use Mechanical Lithotriptor V BML-V442QR-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 04953170218422), received between Jul 25, 2018 and Aug 13, 2026 — classified as 1 death, 37 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Break” (148 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Dec 16, 2024Class IIOpen, Classified

   Potential for distal tip tearing of the Mechanical Lithotriptor V.

   Z-0962-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235853 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE THE TAB THROUGH WHICH THE GUIDE IS INSERTED WAS BROKEN AND IT CAME OUT. THIS ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818429 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE SINGLE-USE MECHANICAL LITHOTRIPTOR DISTAL TIP TORE/BROKE OFF. DUE TO THE REPORTED ISSUE, THERE WAS A 20¿25 MINUTE DELAY IN THE PROCEDURE. THE PATIENT WAS SEDATED WITH PCS-PATIENT CONTROLLED SEDATION. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355944 ↗
• MalfunctionJan 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255647 ↗
• MalfunctionDec 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBJECT DEVICE DISTAL TIP IS TORN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021098 ↗
• MalfunctionNov 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THAT THE DISTAL TIP OF THE SUBJECT DEVICE FOR PASSING GUIDEWIRE WAS TORN. THE PROCEDURE WAS FINISHED USING A REPLACEMENT DEVICE. THE ISSUE OCCURRED, DURING A LITHOTRIPSY PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695771 ↗
• MalfunctionNov 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBJECT EXHIBITED A TORN DISTAL TIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664844 ↗
• MalfunctionOct 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V TIP WAS TORN. THE ISSUE OCCURRED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME MODEL AND THERE WAS NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460215 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V TIP WAS TORN. THE EVENT OCCURRED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392490 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR DISTAL GUIDEWIRE TIP BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369579 ↗
• MalfunctionSep 26, 2024Material Perforation; Material Perforation

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SINGLE USE MECHANICAL LITHOTRIPTOR V EXHIBITED DISTAL TIP FOR PASSING GUIDEWIRE WAS TEARED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311129 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE GUIDEWIRE TIP OF THE MECHANICAL LITHOTRIPTOR HAD CRACKED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263623 ↗
• MalfunctionSep 18, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE SINGLE USE MECHANICAL LITHOTRIPTOR WIRE WOULD NOT THREAD THROUGH THE DISTAL END INTENDED TO GUIDE THE DEVICE INTO THE DUCT. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248997 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE USE MECHANICAL LITHOTRIPTOR V EXHIBITED A DETACHED DISTAL TIP FOR PASSING THE GUIDEWIRE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239028 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THE LITHOTRIPTOR V EXPERIENCED TORN GUIDEWIRE TIP. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WAS NO REPORTED DELAY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237035 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THE MECHANICAL LITHOTRIPTOR'S TIP THAT WAS USED TO CRUSH THE STONE, BROKE OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC LITHOTRIPSY PROCEDURE AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186391 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THE MECHANICAL LITHOTRIPTOR V EXPERIENCED BROKEN DISTAL TIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170066 ↗
• MalfunctionSep 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE SINGLE USE MECHANICAL LITHOTRIPTOR DISTAL TIP FOR PASSING GUIDEWIRE WAS TORN. THE ISSUE OCCURRED DURING LITHOTRIPSY PERFORMED FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129660 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE BASKET ON THE SINGLE USE MECHANICAL LITHOTRIPTOR WAS BROKEN. THE ISSUE OCCURRED DURING THE PREPARATION FOR THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091572 ↗
• MalfunctionAug 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP PART OF THE BASKET ON THE MECHANICAL LITHOTRIPTOR WAS TORN WHEN GOING THROUGH THE GUIDE WIRE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME TYPE OF EQUIPMENT. THERE WAS NO DELAY IN PROCEDURE AND NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087242 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE SINGLE-USE MECHANICAL LITHOTRIPTOR WIRE COULD NOT BE THREADED. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A SIMILAR DEVICE. THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041202 ↗
• MalfunctionAug 22, 2024Crack; Crack

  IT WAS REPORTED WHILE PREPARING ACCESSORIES FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PLASTIC POSITIONED ON THE TIP OF THE SINGLE USE MECHANICAL LITHOTRIPTER CRACKED AND THE GUIDEWIRE CAME OUT LATERALLY. THE ISSUE CAUSED A SLIGHT DELAY OF 5 MINUTES AND THERE WAS PROLONGATION OF ANESTHESIA. THE DEVICE WAS REPLACED , AND THE PROCEDURE WAS THEN PERFORMED AND COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040638 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE SINGLE-USE MECHANICAL LITHOTRIPTOR WIRE COULD NOT BE THREADED. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A SIMILAR DEVICE. THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040112 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE SINGLE-USE MECHANICAL LITHOTRIPTOR WIRE COULD NOT BE THREADED. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A SIMILAR DEVICE. THE PATIENT WAS UNDER PROPOFOL SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033981 ↗
• MalfunctionAug 22, 2024Break; Break

  THE PROCEDURE WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WAS NO DELAY TO THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024459 ↗