Single Use Mechanical Lithotriptor VRecalls & reported problems across all models

We found 6 models of Single Use Mechanical Lithotriptor V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 359 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2018 and Aug 13, 2026 — classified as 3 deaths, 83 injuries, 273 malfunctions.

The most frequently reported specific device problem is “Break” (192 reports).

1 FDA recall record name at least one of these models by its device 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. 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

Single Use Mechanical Lithotriptor V recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 16, 2024Open, 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 Single Use Mechanical Lithotriptor V problems

Single Use Mechanical Lithotriptor V models

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

• Single Use Mechanical Lithotriptor V BML-V442QR-30

  Lithotriptor, biliary mechanical
  1 recall1 death269 reports
• Single Use Mechanical Lithotriptor V BML-V437QR-30

  Lithotriptor, biliary mechanical
  33 reports
• Single Use Mechanical Lithotriptor V BML-V242QR-30

  Lithotriptor, biliary mechanical
  21 reports
• Single Use Mechanical Lithotriptor V BML-V437QR-30

  Lithotriptor, Biliary Mechanical
  21 reports
• Single Use Mechanical Lithotriptor V BML-V232QR-30

  Lithotriptor, biliary mechanical
  2 deaths12 reports
• Single Use Mechanical Lithotriptor V BML-V232QR-26

  Lithotriptor, biliary mechanical
  3 reports

Recent Single Use Mechanical Lithotriptor V adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJul 30, 2026Break

  It was reported that during a therapeutic Endoscopic Retrograde Cholangiopancreatography while removing a stone, the basket cable broke in the proximal area. The doctor used the emergency Lithotriptor handle an attempt to remove the single use mechanical Lithotriptor and the cable broke again, this time in the distal area, next to the basket, leaving the stone and the basket inside the patient. As such the procedure was delayed for equal to or greater then 30 minutes under sedation, completed with a competitors device. No reports of patient harm.

  Patient problems: Foreign Body In Patient

  MAUDE report 50090758 ↗
• InjuryJun 26, 2026Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE SINGLE USE MECHANICAL LITHOTRIPTOR V, WHICH WAS BEING USED TO CRUSH STONES, BROKE WHILE INSIDE THE PATIENT. WHEN UTILIZING THE EMERGENCY HANDLE, THE FOUR WIRES INSIDE THE DEVICE ALSO BROKE. THE PATIENT WAS SENT FOR SURGERY. SURGERY WAS SUCCESSFUL. THE PATIENT REMAINED HOSPITALIZED. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638966 ↗
• InjuryMay 15, 2026Failure to Cut; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THIS SINGLE USE MECHANICAL LITHOTRIPTOR BASKET FAILED TO CRUSH A STONE. THE PHYSICIAN THEN USED THE EMERGENCY HANDLE. THE STONE WAS CRUSHED AND THE BASKET WAS RETRIEVED FROM THE PATIENT. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191988 ↗
• InjuryMar 5, 2026Break; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ELECTIVE AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE UNDER SEDATION WITH PROPOFOL, THE LOCKING ROD OF THE SINGLE USE MECHANICAL LITHOTRIPTOR BROKE DIRECTLY AT THE END OF THE BML HANDLE, AND REST REMAINED STUCK IN THE HANDLE DURING MECHANICAL LITHOTRIPSY. THE BASKET BROKE OFF FROM THE DEVICE AND REMAINED IN THE PATIENT, WITH THE WIRES STILL ATTACHED AND ACCESSIBLE IN CONTACT WITH THE BASKET. THE BASKET ITSELF HAD ENCLOSED A LARGE INTRADUCTAL CALCULUS AND COULD NOT INITIALLY BE REMOVED FROM THE DHC. AN EMERGENCY LITHOTRIPSY SET FROM A THIRD-PARTY COMPANY WAS THEN USED. THE WIRES WERE INSERTED INTO THIS DEVICE AND THE STONE WAS LITHOTRIPSIED, AND THE DEFECTIVE BASKET WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT BY PULLING IT OUT BY WIRES OF THE OTHER DEVICE BUT THE CONCRETIONS REMAINED INSIDE THE BILE DUCT. THE PATIENT THEN UNDERWENT FURTHER TREATMENT, INCLUDING STENT PLACEMENT AND PLAN A CHOLANGIOSCOPY WITH EHL. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY OF APPROXIMATELY 40 MINUTES THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WERE NO REPORTS OF PATIENT HARM OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525833 ↗
• InjuryFeb 18, 2026Break; Detachment of Device or Device Component

  NO RELEVANT ADDITIONAL INFORMATION SUBMITTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378347 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR HAD BASKET BREAK. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897792 ↗
• MalfunctionSep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE LITHOCRUSH WIRES DETACHED FROM THE SHEATH OF THE SUBJECT DEVICE, CAUSING A SLIGHT DELAY. THE BASKET AND STONES WERE SUCCESSFULLY RETRIEVED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071955 ↗
• 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 ↗
• InjuryAug 6, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE METAL COIL SHEATH WAS PUSHED ON THE PLASTIC SHEATH OF THE SUBJECT DEVICE TO CRUSH THE STONE BUT BECAME STUCK AND COULD NOT PUSH THE COIL SHEATH ANYMORE. THE PLASTIC TUBE BECAME COMPRESSED, AND THE SHAPE CHANGED. 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 22728547 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V HAD A FAULT OCCUR WHILST INSIDE PATIENT. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395839 ↗
• MalfunctionJun 26, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECPW) PROCEDURE, THE STONE HAD ALREADY BEEN CAUGHT AND WAS ABOUT TO BE CRUSHED, THE KNOB FOR CRUSHING/CLOSING THE SUBJECT DEVICE BROKE OFF WITH THE TOOL/HANDLE STUCK. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338685 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE BASKET¿S STEM SNAPPED WHILE ATTEMPTING TO CRUSH A BILIARY STONE. THIS ISSUE OCCURRED DURING A UNKNOWN THERAPEUTIC PROCEDURE. THE EMERGENCY HANDLE WAS THEN USED TO COMPLETE THE PROCEDURE. WHILE USING THE EMERGENCY HANDLE TO CRUSH THE STONE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109898 ↗
• MalfunctionMay 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISTAL TIP FOR PASSING GUIDEWIRE WAS TORN AND BROKEN GUIDEWIRE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104880 ↗
• MalfunctionMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SILICONE RAIL INTO WHICH THE GUIDE WIRE IS INSERTED INTO ON THE LITHOTRIPTOR WAS TORN. THE REPORTED ISSUE OCCURRED DURING SET UP AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098646 ↗

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