Wittich G05877Recalls & reported problems
Cook Incorporated · Wittich Nitinol Stone Basket · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002058774), received between Dec 14, 2017 and May 5, 2021 — classified as 3 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation8
- Detachment of Device or Device Component3
- Separation Problem2
- Break1
- Fitting Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Code Available3
- No Consequences Or Impact To Patient3
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A WITTICH NITINOL STONE BASKET WAS INSPECTED PRIOR TO USE. THE CUSTOMER REPORTED THE PACKAGE WAS RIPPED. A PHOTO WAS PROVIDED SHOWING THE SEAL MISSING FROM THE PACKAGE. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11776918 ↗MalfunctionNov 4, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A WITTICH NITINOL STONE BASKET FOR A BILIARY STONE REMOVAL AFTER PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE. DURING THE PROCEDURE, THE OPERATOR GRABBED THE STONE AND PULLED IT TOWARD THE SHEATH. WHILE PULLING THE BASKET, THE SHEATH SEPARATED FROM THE HUB. THE SEPARATED SECTION OF THE DEVICE REMAINED OUTSIDE THE PATIENT'S BODY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10787869 ↗MalfunctionNov 4, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A WITTICH NITINOL STONE BASKET FOR A BILIARY STONE REMOVAL AFTER PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE. DURING THE PROCEDURE, THE OPERATOR GRABBED THE STONE AND PULLED IT TOWARD THE SHEATH. WHILE PULLING THE BASKET, THE SHEATH SEPARATED FROM THE HUB. THE SEPARATED "PARTS" WERE RECOVERED FROM THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 10787292 ↗InjuryNov 3, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A WITTICH NITINOL STONE BASKET FOR A PERCUTANEOUS BILIARY STONE REMOVAL PROCEDURE. THE DEVICE WAS PLACED IN THE BILIARY DUCT FOR BETWEEN THIRTY MINUTES AND ONE HOUR. DURING THE PROCEDURE, THE DEVICE SEPARATED AT THE SOLDER SITE ON THE METAL STYLET WHILE MANIPULATING THE DEVICE IN THE BILIARY TRACT. A RETRIEVAL SNARE WAS REQUIRED TO REMOVE THE SEPARATED PORTION OF THE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10780075 ↗InjuryOct 15, 2020Material Separation; Material Separation
ADDITIONAL INFORMATION RECEIVED 26OCT2020 STATED THE TWO DEVICES FAILED DURING DIFFERENT PROCEDURES. THIS REPORT WILL CAPTURE THE DEVICE IN WHICH THE METAL WIRE SEPARATED FROM THE DILATOR. PRELIMINARY ANALYSIS OF THE RETURNED DEVICE ON (B)(6) 2020 SHOWED THE METAL WIRE AND BASKET COMBINATION SEPARATED FROM THE DILATOR MATERIAL, BUT OTHERWISE INTACT. IT WAS STATED THAT RETRIEVAL OF A DEVICE FRAGMENT WAS REQUIRED, HOWEVER DETAILS REGARDING THE INTERVENTION ARE NOT CURRENTLY AVAILABLE. NO OTHER ADVERSE EFFECTS WERE REPORTED. THE DEVICE MENTIONED IN THE INITIAL REPORT THAT SEPARATED AT THE BASKET SOLDER SITE WILL BE REPORTED UNDER MEDWATCH REPORT #: 1820334-2020-01999.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 10684207 ↗MalfunctionFeb 18, 2020Material Separation; Material Separation
ADDITIONAL INFORMATION RECEIVED ON 20FEB2020 CONFIRMED THE DEVICES ONLY SEPARATED AT THE HUB. BASKET SEPARATION DID NOT OCCUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9721602 ↗InjuryNov 12, 2019Material Separation; Material Separation
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 CONFIRMED THERE WERE NO ADDITIONAL PROCEDURES PERFORMED, FRACTURED PORTION WAS RECOVERED DURING THE ORIGINAL PROCEDURE.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 9311813 ↗MalfunctionMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED A WITTICH NITINOL STONE BASKET WAS USED IN AN UNKNOWN PATIENT FOR A BILIARY STONE REMOVAL PROCEDURE. AS REPORTED THE "BASKET SHEATH AND HUB SEPARATED TOO EASY (SIC)". THE USER ATTEMPTED TO USE ANOTHER DEVICE FROM THE SAME LOT BUT EXPERIENCED THE SAME FAILURE. NO PORTION OF THE DEVICES WERE LEFT INSIDE THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8651168 ↗MalfunctionMar 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8435975 ↗MalfunctionFeb 20, 2019Separation Problem; Separation Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8355459 ↗MalfunctionFeb 20, 2019Separation Problem; Separation Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8354629 ↗MalfunctionJul 3, 2018Material Separation; Fitting Problem; Material Separation; Fitting Problem
IT WAS REPORTED A WITTICH NITINOL STONE BASKET SEPARATED AT THE HUB, PROXIMAL END, UPON INSERTION INTO BILIARY TRACK FOR STONE REMOVAL. IT IS UNKNOWN IF RESISTANCE WAS FELT WHILE INSERTING THE DEVICE, HOWEVER, NO DEVICE COMPONENTS WERE RETAINED BY THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7660443 ↗MalfunctionJun 27, 2018Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7642341 ↗MalfunctionApr 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SHEATH AND HUB SEPARATED ON A WITTICH NITINOL STONE BASKET UPON INSERTION. THE DEVICE WAS REMOVED AND A NEW LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE AS ANTICIPATED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7442506 ↗MalfunctionDec 14, 2017Break
THE BASKET BAR BROKE. NO ADVERSE EVENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7118139 ↗
Other DISLODGER, STONE, BILIARY devices
- Memory Basket G25149Cook Incorporated · DISLODGER, STONE, BILIARY75 reports
- Stonetome M00535110Boston Scientific Corporation · DISLODGER, STONE, BILIARY74 reports
- Stonetome M00535150Boston Scientific Corporation · DISLODGER, STONE, BILIARY67 reports
- Cook G36250Cook Incorporated · DISLODGER, STONE, BILIARY1 recall10 reports
- NCompass G36251Cook Incorporated · DISLODGER, STONE, BILIARY1 recall8 reports
- Strange G09108Cook Incorporated · DISLODGER, STONE, BILIARY1 recall1 report
- Single Use Retrieval Nitinol Basket V FG-V451POlympus Medical Systems Corp. · DISLODGER, STONE, BILIARY31 reports
- SpyGlass™ Retrieval Basket M00546550Boston Scientific Corporation · DISLODGER, STONE, BILIARY23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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