NCircle G17627Recalls & reported problems
Cook Incorporated · NCircle, Nitinol Tipless Stone Extractor · Class 2
Quick summary
This Cook NCircle tipless stone extractor is a nitinol wire basket used to grab and remove kidney stones through a scope during ureteroscopy. Most of the 33 reports describe the basket wire breaking or coming apart, sometimes during use and sometimes already broken when the package was opened, along with wires separating and baskets that were hard to open or would not come back out. One report involved an injury. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00827002176270), received between Jul 12, 2016 and Sep 29, 2026 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Difficult to Open or Close9
- Device Operates Differently Than Expected4
- Material Separation4
- Loss of or Failure to Bond3
- Detachment Of Device Component1
- Device Inoperable1
- Difficult or Delayed Positioning1
Patient problems
- No Consequences Or Impact To Patient17
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient7
- No Patient Involvement2
- Foreign Body In Patient1
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 35 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 50931223 ↗MalfunctionSep 18, 2026Break
As reported. during an URSL ( Ureteroscopic Lithotripsy) procedure, the basket detached from the NCIRCLE TIPLESS STONE EXTRACTOR. The doctor used another unspecified device to remove the detached basket from the patient's body. A new NCIRCLE TIPLESS STONE EXTRACTOR 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.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819832 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT TWO NCIRCLE TIPLESS STONE EXTRACTOR¿S BASKET WIRES "SNAPPED" DURING IN RETROGRADE INTRARENAL SURGERY (RIRS) WHILE RETRIEVING A STONE. THE DEVICE DID NOT SEPARATE INSIDE THE PATIENT, AND NOTHING HAD TO BE REMOVED. 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 24367145 ↗MalfunctionFeb 5, 2026Break
AS REPORTED, DURING URETEROSCOPY PROCEDURE FOR STONE REMOVAL, THE BASKET WIRE OF 'NCIRCLE TIPLESS STONE EXTRACTOR' BROKE OFF INTO THE PATIENT BUT WAS RETRIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT NOT AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267994 ↗MalfunctionDec 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF AN NCIRCLE TIPLESS STONE EXTRACTOR PRIOR TO A URETEROSCOPY PROCEDURE (URSL), THE USER FOUND THAT ONE LINE OF THE BASKET WIRE WAS "BROKEN". THE PROCEDURE WAS COMPLETED USING A NEW NCIRCLE TIPLESS STONE EXTRACTOR. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693721 ↗MalfunctionOct 30, 2025Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break
IT WAS REPORTED THAT THE BASKET WIRE OF AN NCIRCLE TIPLESS STONE EXTRACTOR WAS OBSERVED TO BE BROKEN DURING AN URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. PRIOR TO USE, THE USER TESTED THE DEVICE AND NOTED THAT THE BASKET WIRE WAS BROKEN WHEN OPENING AND CLOSING THE DEVICE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR-LIKE 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 23424420 ↗MalfunctionSep 3, 2025Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break
IT WAS REPORTED DURING A URETEROSCOPIC LASER SURGERY (URSL) PROCEDURE, THE PHYSICIAN USED THE NCIRCLE TIPLESS STONE EXTRACTOR AND FOUND THE LINE WAS BROKEN. THE DOCTOR USED ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. A CUSTOMER PROVIDED PHOTO APPEARS TO SHOW A BASKET WIRE PULLED FREE ON ONE END. 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 22955726 ↗MalfunctionJul 30, 2025Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation
IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, THE BASKET OF A NCIRCLE TIPLESS STONE EXTRACTOR WAS OUT OF SHAPE AFTER ENTERING THE MIRROR. THE PHYSICIAN USED ANOTHER SAME TYPE DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 22670221 ↗MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, THE TIPLESS BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR FELL OFF AND FLOWED FROM THE URETER TO THE RENAL PELVIS AND COULD NOT BE TAKEN OUT. THE BASKET WAS TAKEN OUT AND THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL 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 22092447 ↗MalfunctionDec 3, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9402895 ↗MalfunctionNov 22, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORTED WAS SUBMITTED ON 22DEC2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9361590 ↗MalfunctionSep 25, 2019Material Frayed; Material Frayed
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 25SEP2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119931 ↗MalfunctionJul 26, 2019Break; Break
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8833138 ↗MalfunctionApr 23, 2019Break; Break
IT IS REPORTED DURING AN UNSPECIFIED PROCEDURE USING A NCIRCLE TIPLESS STONE EXTRACTOR, WHEN THE DOCTOR TRIED TO REMOVE THE STONES, THE EXTRACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AFTER THE DIFFICULTY. NO SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY, AND THE PATIENT DID NOT REQUIRE AND ADDITIONAL PROCEDURES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8541115 ↗MalfunctionApr 22, 2019Mechanical Problem; Mechanical Problem
NO NEW EVENT INFORMATION HAS BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8536344 ↗MalfunctionMar 15, 2019Difficult to Open or Close; Difficult to Open or Close
NEW INFORMATION IDENTIFIED ON 09APR2019. TWO DEVICES WERE RETURNED FOR ANALYSIS. EACH DEVICE HAD A DIFFERENT FAILURE MODE. ADDITIONAL INFORMATION RECEIVED ON 11APR2019: PER FOLLOW UP WITH THE NURSE, THEY HAD TO CUT THE BASKET BECAUSE THE STONE WAS TOO LARGE. AFTER THIS THEY WENT BACK TO THE URETER WITH THE WOLF RIGID URETEROSCOPE AND LASERED THE STONE WITH THE DORNIER H2O HOLMIUM LASER. HE RETRIEVED THE SMALLER FRAGMENTS WITH A NEW BASKET. THE PATIENT IS WELL. THE PATIENT RECEIVED A 6 FR URETER STENT AFTER THE PROCEDURE. THEY CUT THE BASKET WHILE IT WAS INSIDE THE PATIENT. THEY WITHDREW THE INSTRUMENT. THEN THEY INTRODUCED THE INSTRUMENT NEXT TO THE CUTTING BASKET INTO THE URETER. NOW THEY LASER THE STONE AND THEY PULLED OUT THE STONE OUT OF THE URETER. FURTHER CLARIFICATION WAS PROVIDED ON 15APR2019: THE SIZE OF THE STONE THEY WERE ATTEMPTING TO REMOVE WAS BETWEEN 0.8 AND 1 MM. THE BASKET WAS CUT OUTSIDE THE PATIENT. IT WAS NOT POSSIBLE TO GET THE STONE OUT FROM THE BASKET. IT WAS NOT INSIDE THE PATIENT AND THE PATIENT LEFT THE HOSPITAL WITHOUT COMPLICATIONS. BOTH DEVICES WERE RETURNED FOR THE ISSUES THAT OCCURRED DURING THE SAME CASE. BOTH DEVICES ARE FROM THE SAME LOT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8426113 ↗MalfunctionMar 11, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT INFORMATION AS BEEN PROVIDED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8408894 ↗MalfunctionSep 27, 2018Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, THE BASKET OF THE NCIRCLE TIPLESS STONE EXTRACTOR DOES NOT OPEN PROPERLY (2 WIRES REMAIN CLOSE), MAKING THE STONE EXTRACTION IMPOSSIBLE. ANOTHER NEW IDENTICAL DEVICE WAS USED FOR THE EXTRACTION OF THE STONES. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7915681 ↗MalfunctionJul 12, 2018Break; Break
IT WAS REPORTED BEFORE THE PROCEDURE, THE PHYSICIAN WANTED TO USE THE NCIRCLE TIPLESS STONE EXTRACTOR BUT HE FOUND THE BASKET WIRE WAS BROKEN. THUS, HE USED A NEW NCIRCLE TIPLESS STONE EXTRACTOR TO COMPLETE THE URETEROSCOPY AND LASER STONE FRAGMENTATION (URSL) PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7681287 ↗MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE NURSE HAS OPENED THE STERILE PACKAGE AND TRIED TO TEST THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET, IT COULD NOT OPEN (BASKET NOT ACTIVE). THE DEVICE WAS NOT USED ON THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7659770 ↗MalfunctionApr 24, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT THE PHYSICIAN USED A NCIRCLE TIPLESS STONE EXTRACTOR DURING A URETEROSCOPIC LITHOTRIPSY, BUT THE FRONT END OF THE BASKET BEGAN TO BEND AND WOULD NOT ALLOW TO GRAB THE STONE SMOOTHLY. THE PHYSICIAN THEN USED ANOTHER EXTRACTOR TO FINISH THE PROCEDURE. 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 Consequences Or Impact To Patient
MAUDE report 7454743 ↗MalfunctionMar 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THE BASKET ON A NCIRCLE TIPLESS STONE EXTRACTOR WOULD NOT COMPLETELY RETRACT. THIS DEVICE WAS BEING USED OFF LABEL FOR A CHOLECYSTECTOMY. THE INSTRUCTIONS FOR USE STATE THIS DEVICE IS INTENDED TO MANIPULATE AND REMOVE STONES IN THE URINARY TRACT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7376988 ↗MalfunctionDec 21, 2017Detachment Of Device Component; Detachment Of Device Component
THE USER FACILITY REPORTED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE, UPON RETRIEVAL OF THE PATIENT'S STONE, THE NCIRCLE TIPLESS STONE EXTRACTOR HANDLE AND SHEATH SEPARATED. THE PHYSICIAN OPENED A NEW NCIRCLE TIPLESS STONE EXTRACTOR AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE REPORTER STATED THAT NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. ALSO STATED WAS THAT THERE WERE NO ADVERSE EVENTS RELATED TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7138709 ↗MalfunctionDec 19, 2017Break; Material Rupture
THE COMPLAINANT REPORTED THAT THE BASKET WIRE WAS "RUPTURED" ON THE FIRST TIME THE PHYSICIAN USED IT. IT WAS FURTHER NOTED THAT ONE OF THE WIRES ON THE BASKET WAS CUT (BROKEN). THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO FINISH THE URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7129811 ↗MalfunctionDec 19, 2017Break
A LASER LITHOTRIPSY STONE EXTRACTION WAS PERFORMED AND THE STONE EXTRACTOR WAS PLACED DOWN THE SCOPE TO RETRIEVE THE STONE. THE DEVICE WAS DEPLOYED AND THE WIRE BROKE IN HALF AS THEY WERE TRYING TO CLOSE THE BASKET. THE DEVICE WAS REMOVED FROM THE SCOPE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7128497 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
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- 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
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.