Single Use Retrieval Basket VRecalls & reported problems across all models
Olympus Medical Systems Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 1
- Injuries reported
- 21
- Recalls
- 0
We found 4 models of Single Use Retrieval Basket V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2018 and Sep 3, 2025 — classified as 1 death, 21 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (16 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. 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
Reports received per month, all models
Most reported Single Use Retrieval Basket V problems
Device problems
- Break16
- Difficult to Remove6
- Detachment of Device or Device Component5
- Adverse Event Without Identified Device or Use Problem3
- Entrapment of Device2
- Obstruction of Flow2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Foreign Body In Patient6
- No Code Available6
- Hemorrhage/Blood Loss/Bleeding2
- Perforation2
- No Consequences Or Impact To Patient1
Single Use Retrieval Basket V models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Retrieval Basket V FG-V422PREndoscopic grasping/cutting instrument, non-powered1 death11 reports
- Single Use Retrieval Basket V FG-V432PEndoscopic grasping/cutting instrument, non-powered11 reports
- Single Use Retrieval Basket V FG-V431PEndoscopic grasping/cutting instrument, non-powered5 reports
- Single Use Retrieval Basket V FG-V421PREndoscopic grasping/cutting instrument, non-powered4 reports
Recent Single Use Retrieval Basket V adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗InjuryMay 21, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED DURING SEDATION OF A THERAPEUTIC LARGE STONE REMOVAL THE BASKET WAS STUCK IN THE COMMON BILE DUCT AND THE BASKET ENVELOPED THE STONE, WIRES /SHEATH TWISTED, WIRES HAD TO BE CUT, GI DOC DILATED THE COMMON BILE DUCT MULTIPLE TIMES, UNTIL FINALLY STONE WAS RELEASED 2 HOURS LATER RESULTING IN A PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063560 ↗InjuryMay 21, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED DURING SEDATION OF A THERAPEUTIC LARGE STONE REMOVAL THE BASKET WAS STUCK IN THE COMMON BILE DUCT AND THE BASKET ENVELOPED THE STONE, WIRES /SHEATH TWISTED, WIRES HAD TO BE CUT, GI DOC DILATED THE COMMON BILE DUCT MULTIPLE TIMES, UNTIL FINALLY STONE WAS RELEASED 2 HOURS LATER RESULTING IN A PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063541 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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