Single Use Retrieval Basket V FG-V432PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170244063), received between Jul 10, 2020 and Dec 10, 2024 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Break; Break

  IT WAS REPORTED THERE WAS AN EXTENSION OF THE PROCEDURE GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894777 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD A BROKEN GUIDEWIRE TIP. THE ISSUE OCCURRED, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. IT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612897 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE BASKET ON THE SINGLE USE RETRIEVAL BASKET 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 20091694 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SINGLE USE RETRIEVAL BASKET V WAS BROKEN. THIS DAMAGE WAS OBSERVED BEFORE ANY PATIENT INTERACTION OR USE OF THE DEVICE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086650 ↗
• InjuryMay 14, 2024Break; Break

  IT WAS REPORTED THE WIRE BASKET BROKE DURING AN EMERGENCY LITHOTRIPSY PROCEDURE. THE BASKET BROKE THE STONE, BUT THE CONTROL CABLE WAS CUT APPROXIMATELY 10 CENTIMETERS FROM THE BASKET. THERE WAS NO IMPACT TO THE PATIENTS' HEALTH AND THE DISTAL PART OF THE BASKET WAS RECOVERED WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316996 ↗
• MalfunctionDec 22, 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 18387726 ↗
• 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 18372567 ↗
• InjuryOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING A SINGLE SUE RETRIEVAL BASKET, THE PHYSICIAN PREPARED TO TAKE THE STONE OUT WITH THE BASKET. AFTER THE STONE WAS TRAPPED, IT WAS NOT PULLED OUT. A SECOND ATTEMPT WAS MADE. AT THIS TIME, IT WAS DISCOVERED THERE WAS A BREAKAGE ABOUT 15CM FROM THE FRONT OF THE BASKET. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN PIECE USING AN ENDOSCOPE BUT WAS UNSUCCESSFUL. THERE WAS NO PATIENT INJURY DURING THE PROCEDURE. THE SUSPECT DEVICE CANNOT BE RETURNED TO OLYMPUS FOR EVALUATION, AS IT WAS DISCARDED AFTER THE PROCEDURE. AFTER THE EVENT, AND X-RAY WAS PERFORMED TO LOCATE THE FRAGMENT IN THE INTESTINAL TRACT. ADDITIONAL DETAILS WERE REQUESTED FROM THE FACILITY. THE FACILITY COULD PROVIDE NO FURTHER INFORMATION DUE TO PRIVACY LAWS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15651685 ↗
• InjuryMar 21, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH COMMON BILE DUCT) CBD) STONE REMOVAL USING A SINGLE USE RETRIEVAL BASKET V, THE BASKET GOT STUCK INSIDE THE CBD WITH THE STONE INSIDE. IT WAS NOT POSSIBLE TO EJECT THE STONE FROM THE BASKET, SO THE PHYSICIAN SWITCHED TO THE EMERGENCY LITHOTRIPTOR / BML-110. ALL COMPONENTS WERE CORRECTLY ASSEMBLED. WHILE TRYING TO CRUSH THE STONE / BREAK THE BASKET TO GET THE DEVICE OUT, THE WIRES OF BASKET BROKE INSIDE THE METALLIC COILED SHEATH OF DEVICE INSTEAD OF BASKET BREAKING AT DISTAL END / TIP. NO EXCESSIVE FORCE WAS USED DURING LITHOTRIPSY ATTEMPT, USED THE RATCHET AS INSTRUCTED (CLICK BY CLICK WITH PAUSES IN BETWEEN OF APPROX. 1 MIN.). AFTER THE WIRES BROKE , THE PHYSICIAN USED A SNARE TO PICK UP THE BROKEN WIRES PIECES THAT WERE INSIDE THE PATIENT AND PULLED THEM BACK INTO THE SHEATH AGAIN TO CONTINUE PROCEDURE. IN THE END THE PHYSICIAN USED TRACTION TO GET THE STONE AND BASKET OUT. AS A PREVENTIVE MEASURE, THE PHYSICIANS DECIDED TO PLACE A COVERED METAL STENT (IN CASE BLEEDING SHOULD OCCUR). THE PROCEDURAL TIME SURPASSED NORMAL ERCP DURATION. (TOTAL PROCEDURE TIME APPROX. 2 HRS.). THE PATIENT WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 13839988 ↗
• InjuryMar 4, 2022Entrapment of Device; Entrapment of Device

  THE CUSTOMER REPORTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE REMOVAL USING A SINGLE USE RETRIEVAL BASKET V, STONES GOT STUCK IN THE BASKET. THE PHYSICIAN USED THE EMERGENCY MECHANICAL LITHOTRIPTOR HANDLE IMMEDIATELY TO COIL THE BASKET BUT THE WIRE SNAPPED. ULTIMATELY THE REMAINING WIRE WAS TOO SHORT TO BE COILED AND PATIENT HAD TO UNDERGO AN EMERGENCY PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM AND MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY (MRCP) TO REMOVE THE BASKET. THE PATIENT WAS SCHEDULED FOR A SECOND ERCP TO REMOVE THE REMAINING STONE BURDEN. THERE WERE NO ADDITIONAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13667492 ↗
• MalfunctionJul 10, 2020Difficult to Remove; Difficult to Remove

  WE RECEIVED THE FOLLOWING REPORT. DURING AN ENDOSCOPIC REMOVAL OF A LARGE STONE (CONCRETION), THE SUBJECT DEVICE WAS USED. THE SUBJECT DEVICE COULD NOT BE REMOVED FROM THE PATIENT BODY. THE USER USED THE EMERGENCY LITHOTRIPTOR, BUT THE USER COULD NOT REMOVE THE SUBJECT DEVICE SINCE THE BASKET WIRE WAS NOT BROKEN OFF, BUT THE OPERATING WIRE WAS BROKEN OFF AT THE PROXIMAL SIDE. THE PATIENT WAS INTUBATED UNTIL THE FOLLOWING DAY AND THE STONE WAS REMOVED WITHOUT FURTHER CONSEQUENCES. THIS IS THE REPORT REGARDING THE FAILURE OF THE DEVICE'S REMOVAL.

  Patient problems: No Code Available

  MAUDE report 10257222 ↗