NCircle G19110Recalls & reported problems
Cook Incorporated · NCircle, Nitinol Tipless Stone Extractor Delta Wire, Basket · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cook NCircle stone extractor is a wire basket used to catch and remove urinary stones during endoscopic procedures. Of its 90 reports, 4 describe injuries and no deaths are recorded. Reports mostly describe the basket not opening or closing, wires that bent, twisted or broke, and stones falling out during removal. Most reports describe no impact on the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00827002191105), received between Mar 28, 2016 and Sep 29, 2026 — classified as 4 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (51 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close51
- Break16
- Device Operates Differently Than Expected9
- Difficult or Delayed Positioning7
- Material Separation4
- Component Missing3
- Material Deformation3
- Device Damaged by Another Device2
Patient problems
- No Consequences Or Impact To Patient40
- No Clinical Signs, Symptoms or Conditions19
- No Patient Involvement15
- No Known Impact Or Consequence To Patient12
- No Code Available2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938712 ↗MalfunctionJun 16, 2026Difficult to Open or Close
IT WAS REPORTED THAT THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WOULD NOT OPEN DURING A TRANSURETERAL SOFT ENDOSCOPY LITHOTRIPSY AND RETROGRADE INTRARENAL SURGERY (RIRS) STONE REMOVAL PROCEDURE. THE BASKET CLOSURE TEST WAS PERFORMED BEFORE USE, WHICH WAS NORMAL. AFTER ABOUT 2 STONE EXTRACTIONS, THE BASKET FAILED TO OPEN. THE USER CHANGED TO A NEW BASKET TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25521010 ↗MalfunctionFeb 5, 2026Break; Difficult to Open or Close; Material Deformation
AS REPORTED, DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE, THE BASKET WIRE OF 'NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR' BECAME TWISTED AND WOULD NOT CLOSE. THIS ISSUE OCCURRED WHEN THE USER OPENED THE PRODUCT AND ATTEMPTED TO CLOSE THE BASKET FROM THE INITIAL OPEN STATE. THE USE WAS DISCONTINUED SINCE IT STOPPED MOVING. THE SAME ISSUE OCCURRED CONSECUTIVELY IN FOUR UNITS FROM THE SAME LOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT LOT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267902 ↗MalfunctionJan 28, 2026Difficult to Open or Close
IT WAS REPORTED A COOK NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS DEFECTIVE DURING AN UNSPECIFIED PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24198420 ↗MalfunctionJan 26, 2026Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176955 ↗MalfunctionJan 19, 2026Break
IT WAS REPORTED, DURING TRANSURETHRAL URETEROSCOPY LITHOTRIPSY AND STONE REMOVAL PROCEDURE, THE SHEATH OF AN NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BROKE AT HANDLE CONJUNCTION AREA, AND THE BASKET COULD NOT BE CLOSED OR OPENED. THE DEVICE WAS TESTED PRIOR TO PATIENT CONTACT AND FUNCTIONED PROPERLY. A NEW BASKET WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111451 ↗MalfunctionDec 2, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, DURING TRANSURETHRAL LITHOTRIPSY (TUL), THE BASKET OF AN NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR DID NOT OPEN/CLOSE CORRECTLY. THE ISSUE WAS DISCOVERED WHEN THE DEVICE WAS TESTED, PRIOR TO PATIENT CONTACT, AND THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697706 ↗MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR¿S BASKET WAS UNABLE TO BE OPENED WHILE BEING TESTED PRIOR TO USE IN TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. DURING THE TEST THE YELLOW COVER AT THE BASE OF THE SHEATH SEVERED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23683329 ↗MalfunctionNov 19, 2025Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597500 ↗MalfunctionAug 25, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS UNABLE TO FULLY CLOSE AND RETRACT DURING URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE. HOWEVER, THIS DID NOT AFFECT THE BASKET´S PERFORMANCE. THE BASKET WAS TESTED PRIOR TO USE AND FUNCTIONED PROPERLY. THE STONE WAS REMOVED WITH THE COMPLAINT DEVICE AND THE CASE ENDED WITH A STENT PLACEMENT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22888880 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED DURING AN UNKNOWN KIDNEY PROCEDURE, THE HEAD OF THE BASKET OF AN NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR SEPARATED FROM THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469467 ↗MalfunctionJun 20, 2025Deformation Due to Compressive Stress; Difficult to Open or Close; Deformation Due to Compressive Stress; Difficult to Open or Close
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299185 ↗MalfunctionJun 3, 2025Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation
IT WAS REPORTED AFTER USING THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR TWO TIMES TO REMOVE STONES DURING A RETROGRADE INTRARENAL SURGERY (RIRS), THE BASKET WOULD NOT OPEN NORMALLY, AND THE STONES COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133577 ↗MalfunctionMay 27, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, PRIOR TO PATIENT CONTACT DURING A RETROGRADE INTRARENAL SURGERY (RIRS) IN THE LEFT KIDNEY, THE USER TESTED THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR AND FOUND THE BASKET COULD NOT BE OPENED TO 30FR DIAMETER WIDE, IT WOULD ONLY OPEN TO AROUND 18 FR VISUALLY. THE OPERATION WAS COMPLETED BY USING ANOTHER SAME TYPE DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22090459 ↗MalfunctionMay 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED A PATIENT UNDERWENT A URETEROSCOPY PROCEDURE WITH STONE MANIPULATION AND LASER LITHOTRIPSY IN WHICH THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS USED. THE EXTRACTOR WAS PLACED IN THE PATIENT FOR A FEW SECONDS AND REMOVED. WHEN REMOVED IT WAS NOTED THE BASKET WAS FLATTENED. IT IS UNKNOWN IF THE DEVICE WAS TESTED PRIOR TO USE. A LASER WAS USED. THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED OR SCARRED ANATOMY. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028090 ↗MalfunctionMay 5, 2025Break; Break
IT WAS INITIALLY REPORTED THAT TWO NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BASKETS FAILED TO CLOSE AND OPEN. THE FAILURE OCCURRED WITH TWO BASKETS. BOTH THE BASKETS WERE TESTED, AND THEY WORKED. DURING THE PROCEDURE, THE FIRST BASKET WOULD NOT CLOSE, AND THE SECOND BASKET WOULD NOT OPEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER STOPPING THE USE OF BASKETS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. TWO DEVICES WERE RETURNED AND THE DEVICES HAD DIFFERENT LOT NUMBERS. REFERENCE MEDWATCH REPORT 1820334-2024-01615 FOR BASKET 1, WHERE IT WAS FOUND UPON INSPECTION NO DAMAGE TO THE DEVICE WAS NOTICED ASIDE FROM BROKEN WIRES COMING FROM DISTAL END OF SHEATH. BASKET 2, THIS REPORT, UPON INSPECTION THE YELLOW SUPPORT TUBING AND SHEATH WAS BROKEN AT THE HANDLE. HANDLE WAS ACTUATED, AND THE BASKET WOULD NOT OPEN/CLOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960408 ↗MalfunctionMar 14, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device
IT WAS REPORTED THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR¿S BASKET WIRE BROKE WHILE REMOVING A STONE DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE IN THE LEFT KIDNEY. NO PART OF THE DEVICE REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE DEVICE WAS TESTED PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604713 ↗MalfunctionMar 12, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device
IT WAS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) TO REMOVE THE STONE LOCATED IN THE LEFT KIDNEY, THE USER DETECTED THE BASKET WIRE OF A NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS BROKEN WHILE CAPTURING THE STONE. ITS USE WAS DISCONTINUED. THE DEVICE WAS TESTED BEFORE USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME TYPE DEVICE. A PHOTO OF WHAT APPEARS TO SHOW A BASKET BROKEN WIRE IS ATTACHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584904 ↗MalfunctionMar 6, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE 'NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR' DID NOT OPEN OR CLOSE DURING AN UNSPECIFIED PROCEDURE. THEY COMPLETED THE PROCEDURE USING A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536326 ↗MalfunctionAug 20, 2019Difficult to Open or Close; Difficult to Open or Close
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8911929 ↗MalfunctionJul 22, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW EVENT OR PATIENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 22JUL2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8812955 ↗MalfunctionMay 1, 2019Difficult to Open or Close; Difficult to Open or Close
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 8570084 ↗MalfunctionApr 26, 2019Difficult to Open or Close; Difficult to Open or Close
THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Patient Involvement
MAUDE report 8557442 ↗MalfunctionMar 21, 2019Mechanical Jam; Mechanical Jam
CUSTOMER CONFIRMED THAT THE DEVICE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT. THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER DETAILS ABOUT THE PATIENT OR EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8440040 ↗MalfunctionMar 15, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW EVENT INFORMATION HAS BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8425625 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
- NGage G48295Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL74 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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