Single Use Retrieval Basket V FG-V431PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170244056), received between Apr 9, 2021 and Sep 3, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THE RETRIEVAL BASKET HAD A BROKEN OPERATION WIRE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955390 ↗
• InjurySep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF SINGE USE RETRIEVAL BASKET FELL OFF INTO THE PATIENT'S BODY AND WAS RETRIEVED. THE USER FINISHED THE CASE WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247081 ↗
• MalfunctionDec 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE RETRIEVAL BASKET V, DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WHEN BASKET IS OUT FROM DISTAL END OF ENDOSCOPE (IN FRONT OF PAPILLA) WIRES ARE BROKEN AND SEPARATED FROM WHOLE BASKET. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371851 ↗
• InjuryNov 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A SINGLE USE RETRIEVAL BASKET V, THE BASKET TORE OFF DURING EMERGENCY LITHOTRIPSY AND COULD ONLY BE REMOVED SURGICALLY. THE SUSPECT DEVICE CANNOT BE RETURNED FOR EVALUATION, IT WAS DISCARDED BY THE CUSTOMER. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15809678 ↗
• InjuryApr 9, 2021Break; Difficult to Remove; Break; Difficult to Remove

  OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC STONE REMOVAL USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE SUBJECT DEVICE COULD NOT BE REMOVED FROM THE PATIENT SINCE THE DEVICE BROKE. THE USER TRIED TO REMOVE THE DEVICE WITH THE EMERGENCY LITHOTRIPTOR. HOWEVER, THE WIRE OF THE DEVICE BROKE. THE EMERGENCY LITHOTRIPTOR WAS NO LONGER USABLE SINCE THE WIRE BECAME SHORTER. THE WIRE WAS PROTRUDED FROM THE PATIENT'S NOSE FOR THE TIME BEING. ON THE NEXT DAY, THE USER TOOK PLACE A FOLLOW-UP ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), USED ESWL TO CRUSH THE STONE, AND COULD REMOVE THE DEVICE FROM THE PATIENT. THERE IS NO DETERIORATION OF THE PATIENT'S HEALTH CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11639501 ↗