Single Use Retrieval Basket V FG-V422PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170244049), received between Dec 18, 2018 and Jul 30, 2025 — classified as 1 death, 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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.

• InjuryJul 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672541 ↗
• InjuryFeb 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE BASKET GOT STUCK IN THE BILE DUCT DURING STONE REMOVAL. THE BASKET BROKE AT THE PULLEY. AFTER SEVERAL DIFFERENT MANEUVERS, THE BASKET WAS RETRIEVED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796284 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "REAL-LIFE INDICATIONS AND OUTCOME OF ELECTROCAUTERY-ENHANCED LUMEN-APPOSING METAL STENTS IN A TERTIARY CENTER".LITERATURE SUMMARYPURPOSE:ELECTROCAUTERY-ENHANCED LUMEN-APPOSING STENTS (EC-LAMS) WERE ORIGINALLY DESIGNED FOR THE DRAINAGE OF THE GALLBLADDER, BILE DUCT, AND PANCREAS PSEUDOCYSTS. THROUGHOUT THE YEARS, SEVERAL OFF-LABEL INDICATIONS WERE ESTABLISHED. THIS STUDY AIMS TO EVALUATE THE INDICATION, SAFETY, EFFICACY, AND OUTCOME OF ALL LAMS IMPLANTED IN A SINGLE TERTIARY REFERRAL CENTER.METHODS:FROM APRIL 2016 TO APRIL 2022, ALL PATIENTS UNDERGOING LAMS PLACEMENT IN A SINGLE TERTIARY CENTER WERE INCLUDED. WE PRESENT A DETAILED ANALYSIS OF INDICATIONS, SUCCESS RATES, AND COMPLICATIONS BASED ON A RETROSPECTIVE ANALYSIS OF OUR PROSPECTIVELY MAINTAINED DATABASE.RESULTS:A TOTAL OF 86 STENTS WERE PLACED IN 77 PATIENTS BETWEEN APRIL 2016 AND APRIL 2022. INDICATIONS WERE WALLED-OFF PANCREATIC NECROSIS (25.6%), BILE DUCT OBSTRUCTIONS (16.3%), ACUTE CHOLECYSTITIS (15.1%), PANCREAS PSEUDOCYSTS (15.1%), POSTOPERATIVE COLLECTIONS (10.5%), POSTOPERATIVE PANCREATIC FISTULAS (9.3%), AND GASTRO-GASTROSTOMY/JEJUNOSTOMY (8.1%) TO E

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18543863 ↗
• DeathJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "REAL-LIFE INDICATIONS AND OUTCOME OF ELECTROCAUTERY-ENHANCED LUMEN-APPOSING METAL STENTS IN A TERTIARY CENTER". LITERATURE SUMMARY. PURPOSE: ELECTROCAUTERY-ENHANCED LUMEN-APPOSING STENTS (EC-LAMS) WERE ORIGINALLY DESIGNED FOR THE DRAINAGE OF THE GALLBLADDER, BILE DUCT, AND PANCREAS PSEUDOCYSTS. THROUGHOUT THE YEARS, SEVERAL OFF-LABEL INDICATIONS WERE ESTABLISHED. THIS STUDY AIMS TO EVALUATE THE INDICATION, SAFETY, EFFICACY, AND OUTCOME OF ALL LAMS IMPLANTED IN A SINGLE TERTIARY REFERRAL CENTER. METHODS: FROM (B)(6) 2022, ALL PATIENTS UNDERGOING LAMS PLACEMENT IN A SINGLE TERTIARY CENTER WERE INCLUDED. WE PRESENT A DETAILED ANALYSIS OF INDICATIONS, SUCCESS RATES, AND COMPLICATIONS BASED ON A RETROSPECTIVE ANALYSIS OF OUR PROSPECTIVELY MAINTAINED DATABASE. RESULTS: A TOTAL OF 86 STENTS WERE PLACED IN 77 PATIENTS BETWEEN (B)(6) 2022. INDICATIONS WERE WALLED-OFF PANCREATIC NECROSIS (25.6%), BILE DUCT OBSTRUCTIONS (16.3%), ACUTE CHOLECYSTITIS (15.1%), PANCREAS PSEUDOCYSTS (15.1%), POSTOPERATIVE COLLECTIONS (10.5%), POSTOPERATIVE PANCREATIC FISTULAS (9.3%), AND GASTRO-GASTROSTOMY/JEJUNOSTOMY (8.1%) TO ENABLE TO PERFORM AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18543781 ↗
• InjuryApr 26, 2023Difficult to Remove; Difficult to Remove

  THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT WAS CONFIRMED THAT THE BASKET WAS REMOVED FROM THE PATIENT VIA SURGERY. IN ADDITION, THE PATIENT¿S STATUS WAS REPORTED AS ¿OK.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820882 ↗
• InjuryDec 29, 2022Entrapment of Device; Entrapment of Device

  THE CUSTOMER REPORTS DURING A MECHANICAL LITHOTRIPSY PROCEDURE USING A SINGLE USE RETRIEVAL BASKET, THE DEVICE BROKE ON THE HANDPIECE SIDE. AS A RESULT, THE DEVICE WAS TRAPPED IN THE BILIARY TRACT (DISTAL CHOLE DUCT). THE PROCEDURE WAS DELAYED IN ORDER TO DEPLOY A SPYGLASS CHOLANGIOSCOPY WITH ELECTROHYDRAULIC LITHOTRIPSY TO FRAGMENT THE CALCULUS THAT WAS KEEPING THE DORMIA (BASKET) IMPRISONED. THERE WAS NO HARM TO THE PATIENT. THE PRODUCT WAS NORMALLY INSPECTED BEFORE THE PROCEDURE WITHOUT DETECTING ANY ABNORMALITIES. THE PROCEDURE WAS NOT COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067175 ↗
• InjuryApr 8, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION IN PATIENT WITH ANGIOCHOLITIS. AFTER SUCCESSFULLY EXTRACTING THE STONE LOCATED AT THE LEVEL OF THE BILE DUCT USING THE SUBJECT DEVICE. HOWEVER, WHEN PASSING THROUGH THE CYSTIC DUCT, IT WOULD NOT CROSS THE CYSTIC NECK. THE PHYSICIAN DECIDED TO PERFORM AN EXTRACORPOREAL MECHANICAL LITHOTRIPSY. DURING THE USE OF THE CRANK/HANDLE OF THE LITHOTRIPTOR, THE SUBJECT DEVICE WIRE BROKE. THE PHYSICIAN THEN TRIED TO EXTRACT THE WIRE WITH FOREIGN BODY FORCEPS WHICH WAS UNSUCCESSFUL. MACRODILUTION OF THE CYSTIC NECK WAS PERFORMED AND THE PHYSICIAN WAS STILL UNABLE TO EXTRACT THE BROKEN BASKET. THE BROKEN BASKET WAS LEFT IN THE STOMACH AFTER THE PHYSICIAN PROTECTED THE PROXIMAL EXTREMITY WITH AN ADHESIVE BANDAGE. AN ADDITIONAL SURGERY WILL BE PERFORMED THE 'NEXT WEEK' TO EXTRACT THE BROKEN BASKET BY PERFORMING AN ERCP SPYGLASS AND ENDOCHANNEL LITHOTRIPSY. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 14060292 ↗
• MalfunctionFeb 28, 2020Break; Difficult to Remove; Break; Difficult to Remove

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR A BILE DUCT CLEARANCE, THE SUBJECT DEVICE WAS USED. THE USER REMOVED A PLASTIC PIGTAIL STENT AND FOUND NUMEROUS LARGE CALCULUS IN COMMON BILE DUCT. AFTER A SPHINCTEROTOMY, THE SURGEON TRIED TO REMOVE THE CALCULUS USING A BALLOON, BUT THIS ATTEMPT WAS UNSUCCESSFUL AT THAT TIME. NEXT, THE SURGEON USED THE SUBJECT DEVICE AND CAUGHT THE CALCULUS. HOWEVER, THE USER COULD NOT REMOVE THE CALCULUS AND THE SUBJECT DEVICE FROM THE BILE DUCT. THE SURGEON USED THE EMERGENCY LITHOTRIPTOR. WHILE ROTATING THE HANDLE, ALL THE BASKET WIRES WERE BROKEN OFF NEAR THE HANDLE. THE BASKET SLIPPED OFF THE CALCULUS, IT COULD BE RETRACTED INTO THE SHEATH, AND THE SUBJECT DEVICE WAS REMOVED FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON DEVICE. THE PATIENT WAS TRANSFERRED TO RECOVERY DEPARTMENT FOR OBSERVATION. THERE WAS NO PATIENT INJURY REPORTED AT THIS TIME. THIS IS THE REPORT REGARDING THE FAILURE OF THE REMOVAL OF THE SUBJECT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767969 ↗
• InjuryJun 14, 2019Difficult to Remove; Difficult to Remove

  DURING AN EMERGENCY LITHOTRIPSY WITH A BML-110A, THE PROXIMAL SIDE OF THE BASKET WIRE OF THE SUBJECT DEVICE IS TORN OUTSIDE OF THE PATIENT. THE USER TRIED TO PULL THE WIRE INTO THE TUBE BUT IT WAS FAILED. THE USER TRIED TO GET A MECHANICAL LITHOTRIPTOR BASKET TO PUT IT OVER THE BASKET AND SMASHED THE STONE, UNFORTUNATELY THIS DID NOT WORK. THE PATIENT WAS SEDATED FOR ABOUT 6 HOURS AND HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8698671 ↗
• InjuryDec 25, 2018Difficult to Remove; Difficult to Remove

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE USER TRIED TO RETRIEVE THE CALCULUS WITH THE SUBJECT DEVICE, BUT IT WAS INCARCERATED. WHEN THE INCARCERATION WAS MANAGED USING A LITHOCRUSH (A DEVICE USED TO CRUSH THE CALCULUS), THE BASKET WIRE OF THE LITHOCRUSH BROKE OFF. THE SURGEON DECIDED TO CONDUCT AN OPEN SURGERY TO REMOVE THE SUBJECT DEVICE AND THE CALCULUS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE INCARCERATION OF BILE DUCT STONES.

  Patient problems: No Code Available

  MAUDE report 8194735 ↗
• InjuryDec 18, 2018Break; Break

  DURING A PROCEDURE OF BILE DUCT STONE REMOVAL, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE USER TRIED TO RETRIEVE THE CALCULUS WITH THE SUBJECT DEVICE, BUT IT COULD NOT BE REMOVED FROM THE COMMON BILE DUCT BECAUSE THE CALCULUS WAS LARGE. WHEN THE USER USED AN EMERGENCY LITHOTRIPTOR, THE WIRE OF THE SUBJECT DEVICE BROKE. THE USER PERFORMED SURGERY TO REMOVE THE SUBJECT DEVICE AND THE CALCULUS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE ADDITIONAL PROCEDURE DUE TO BREAKAGE OF THE WIRE.

  Patient problems: No Code Available

  MAUDE report 8177192 ↗