Single Use Mechanical Lithotriptor V BML-V437QR-30 (REF N2303131)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04953170462610), received between Apr 26, 2024 and Jun 26, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE DISTAL TIP FOR THE GUIDEWIRE 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 22095469 ↗
• InjuryMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION PROCEDURE, WHEN THE PHYSICIAN TRIED TO CRUSH THE STONE WITH THE BASKET, THE CABLE BROKE INSIDE THE PATIENT. THE CABLE LINK BARELY CAME OUT OF THE PATIENT'S MOUTH AND IT WAS NOT LONG ENOUGH FOR IT TO FIT THROUGH THE SHEATH TO USE THE EMERGENCY HANDLE. THE STONE AND BROKEN BASKET WERE EVENTUALLY EXTRACTED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR ABOUT 3 HOURS ON (B)(6) 2025 AND THE PATIENT WAS BROUGHT BACK IN ON (B)(6) 2025 AND PROCEDURE LASTED ALMOST 2 HOURS. THE PROCEDURE WAS THEN COMPLETED WITH A LASER, EXTRACTION BALLOON, AND A RAT TOOTH FORCEPS, AND NEEDLE KNIFE. THE PHYSICIAN STATED THERE WERE NO COMPLICATIONS BUT THE STONE WAS UNABLE TO BE CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039486 ↗
• InjuryMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION PROCEDURE, WHEN THE PHYSICIAN TRIED TO CRUSH THE STONE WITH THE BASKET, THE CABLE BROKE INSIDE THE PATIENT. THE CABLE LINK BARELY CAME OUT OF THE PATIENT'S MOUTH AND IT WAS NOT LONG ENOUGH FOR IT TO FIT THROUGH THE SHEATH TO USE THE EMERGENCY HANDLE. THE STONE AND BROKEN BASKET WERE EVENTUALLY EXTRACTED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR ABOUT 3 HOURS ON (B)(6) 2025 AND THE PATIENT WAS BROUGHT BACK IN ON (B)(6) 2025 AND PROCEDURE LASTED ALMOST 2 HOURS. THE PROCEDURE WAS THEN COMPLETED WITH A LASER, EXTRACTION BALLOON, AND A RAT TOOTH FORCEPS, AND NEEDLE KNIFE. THE PHYSICIAN STATED THERE WERE NO COMPLICATIONS BUT THE STONE WAS UNABLE TO BE CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039474 ↗
• MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LITHOCRUSH WIRES ON THE LITHOTRIPTOR DETACHED FROM THE SHEATH. THE REPORTED ISSUE OCCURRED DURING A PROCEDURE, WHICH CAUSED A SLIGHT DELAY. THE BASKET AND STONES WERE SUCCESSFULLY RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766248 ↗
• MalfunctionApr 1, 2025Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V LITHOCRUSH HAD THE WIRES COME COMPLETELY OUT OF THE SHEATH WHEN WE TRIED TO PULL THE BASKET OUT OF THE DUCT. IT OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS A LESS THAN 30 MINUTES DELAY, AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738378 ↗
• MalfunctionMar 31, 2025Defective Device; Defective Device

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V LITHOCRUSH AND THE WIRES CAME COMPLETELY OUT OF THE SHEATH WHEN WE TRIED TO PULL THE BASKET OUT OF THE DUCT. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WAS A LESS THAN 30 MINUTES DELAY, AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21735342 ↗
• InjuryJan 8, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A BILE DUCT LITHOTRIPSY PROCEDURE, THE SUBJECT DEVICE DID NOT COME OUT OF THE SCOPE. AFTER CRUSHING ONE OF THE GALLSTONES, IT WAS INSERTED INTO THE SCOPE AGAIN AND WAS USED TO CRUSH ANOTHER GALLSTONE, BUT IT DID NOT COME OUT OF THE SCOPE. THIS RESULTED TO A DELAY OF PROCEDURE FOR MORE THAT 30 MINUTES WHILE THAT PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS THEN COMPLETED WITH A SIMILAR BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106986 ↗
• InjuryOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC PROCEDURE, THE TIP OF THE SINGLE USE MECHANICAL LITHOTRIPTER FELL OFF INSIDE THE PATIENT'S DUODENUM. IT WAS IMMEDIATELY RETRIEVED AND REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482132 ↗
• MalfunctionOct 18, 2024Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A TEAR AT THE DISTAL TIP FOR PASSING GUIDEWIRE. 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 20480045 ↗
• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V GUIDE WIRE TIP CAME OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170847 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR GUIDEWIRE TIP HAD TORN. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY THERAPEUTIC 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 19966134 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THE LITHOTRIPTOR TIP OF THE GUIDEWIRE CRACKED DURING A THERAPEUTIC ENDOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921382 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT THE SINGLE-USE MECHANICAL LITHOTRIPTOR EXHIBITED ISSUES WHEN ATTEMPTING TO BREAK UP A STONE. THE HANDLE WAS TURNED THREE TIMES, RESULTING IN THE CONNECTION BETWEEN THE BASKET AND THE HANDLE BREAKING. THE STONE WAS NOT LARGE ENOUGH TO BE PULLED OUT OF THE PAPILLA AS IT WAS. THE BROKEN BASKET WAS ALSO PULLED OUT AND RETRIEVED, LEAVING NOTHING IN THE BODY. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661041 ↗
• MalfunctionJun 4, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SINGLE USE MECHANICAL LITHOTRIPTOR V EXHIBITED A SITUATION WHERE THE BASKET COULD NEITHER BE OPENED NOR CLOSED DURING STONE CRUSHING, NECESSITATING THE USE OF THE EMERGENCY HANDLE TO CRUSH THE REMAINING STONES. THE ISSUE WAS FOUND DURING AN UNKNOWN THERAPEUTIC PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464161 ↗
• MalfunctionApr 26, 2024Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  IT WAS REPORTED THAT THE SINGLE-USE MECHANICAL LITHOTRIPTOR BECAME INCARCERATED. THE GALLSTONES WERE STRUCK IN THE BASKET. THE ISSUE WAS FOUND DURING THE PROCEDURE. A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO PANCERATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED. THE PROCEDURE WAS CANCELLED AND WAS DECIDED TO BE PERFORMED AT A LATER DATE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE CANCELLATION. THOUGH THE PROCEDURE WAS DELAYED, THE PATIENT'S CONDITION WAS NOT IMPACTED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19193108 ↗