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NCircle G18778Recalls & reported problems

Cook Incorporated · NCircle, Nitinol Tipless Stone Extractor · Class 2

Quick summary

This Cook NCircle ureteral stone extractor has 231 adverse event reports, including 24 injuries and no deaths. The reports mostly describe the wire or basket breaking and baskets that are difficult to open or close. 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
226
Deaths reported
0
Injuries reported
24
Recalls naming it
0

Summary

The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 00827002187788), received between Mar 4, 2015 and Aug 11, 2026 — classified as 24 injuries, 202 malfunctions.

The most frequently reported specific device problem is “Break” (105 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 5 reportsApr 2025: 3 reportsMay 2025: 3 reportsJun 2025: 8 reportsJul 2025: 2 reportsAug 2025: 1 reportsSep 2025: 3 reportsOct 2025: 3 reportsNov 2025: 7 reportsDec 2025: 3 reportsJan 2026: 3 reportsFeb 2026: 5 reportsMar 2026: 4 reportsApr 2026: 3 reportsMay 2026: 1 reportsJun 2026: 4 reportsJul 2026: 1 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break105
  • Difficult to Open or Close58
  • Material Separation22
  • Device Operates Differently Than Expected14
  • Detachment of Device or Device Component9
  • Loss of or Failure to Bond9
  • Material Deformation9
  • Device Damaged Prior to Use6

Patient problems

  • No Consequences Or Impact To Patient101
  • No Clinical Signs, Symptoms or Conditions60
  • No Known Impact Or Consequence To Patient35
  • No Patient Involvement13
  • Device Embedded In Tissue or Plaque8
  • No Information8
  • Foreign Body In Patient4
  • Complaint, Ill-Defined1

Recent adverse event reports

The 25 most recent of 226 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 11, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50210247 ↗
  • MalfunctionAug 11, 2026Difficult to Open or Close

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50207389 ↗
  • MalfunctionJul 15, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25830425 ↗
  • MalfunctionJun 29, 2026Break

    IT WAS REPORTED THE DISTAL END OF NCIRCLE TIPLESS STONE EXTRACTOR BROKE OFF INSIDE THE PATIENT DURING URETEROSCOPY PROCEDURE FOR A STONE EXTRACTION. THE BROKEN WIRE WAS RETRIEVED WITH ANOTHER EXTRACTOR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE DEVICE WAS TESTED PRIOR TO USE AND LASER WAS USED WHILE THE BASKET WAS USED. IT IS UNKNOWN IF THE PATIENT HAS TORTUOUS, CALCIFIED OR SCARRED ANATOMY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25651991 ↗
  • MalfunctionJun 23, 2026Difficult to Open or Close

    IT WAS REPORTED THAT DURING A TRANSURETHRAL URETEROSCOPIC LITHOTRIPSY WITH STONE FRAGMENTATION AND REMOVAL AN NCIRCLE TIPLESS STONE EXTRACTOR BASKET COULD NOT BE OPENED AFTER FIVE STONE REMOVALS. THE BASKET WAS TESTED PRIOR TO USE AND WAS NORMAL. A NEW BASKET WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25597378 ↗
  • MalfunctionJun 19, 2026Break

    IT WAS REPORTED THE DISTAL END OF NCIRCLE TIPLESS STONE EXTRACTOR BROKE AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH 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 25564066 ↗
  • MalfunctionJun 19, 2026Break

    IT HAS BEEN REPORTED THAT DURING AN URETEROSCOPY PROCEDURE WITH LASER LITHOTRIPSY, A NCIRCLE TIPLESS STONE EXTRACTOR "BROKE" WHILE BEING USED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25562510 ↗
  • MalfunctionMay 28, 2026Difficult to Open or Close

    AS REPORTED, DURING A TRANSURETHRAL FLEXIBLE URETEROSCOPIC LITHOTRIPSY WITH STONE REMOVAL, AN NCIRCLE TIPLESS STONE EXTRACTOR'S BASKET CANNOT BE OPENED COMPLETELY. THE COMPLAINT DEVICE WAS TESTED PRIOR TO USE AND FUNCTIONED PROPERLY. AFTER APPROXIMATELY SEVEN STONE REMOVALS, THE BASKET WAS UNABLE TO BE OPENED COMPLETELY. A NEW BASKET WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25322748 ↗
  • MalfunctionApr 21, 2026Loss of or Failure to Bond

    IT WAS REPORTED THAT ONE BASKET WIRE SEPARATED FROM THE DISTAL NOTCHED CANNULA OF AN NCIRCLE TIPLESS STONE EXTRACTOR DURING A KIDNEY PROCEDURE FOR A FEMALE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS WIRE SEPARATION. 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 24942405 ↗
  • MalfunctionApr 15, 2026Loss of or Failure to Bond; Break

    IT WAS REPORTED, DURING A FLEXIBLE URETEROSCOPY + PYELOSCOPY/LASERTRIPSY (KIDNEY STONE REMOVAL) THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR HAD RUPTURED. THE PATIENT WAS X-RAYED AND THE DRAPE CLOSELY INSPECTED BUT THERE WAS NO SIGN OF THE BASKET. THE EXTRACTOR WAS USED TO REMOVE SEVERAL KIDNEY STONES. WHEN REMOVING THE LAST STONE, THE BASKET WAS OPENED TO GRAB THE STONE AND THE STONE WAS PULLED TO THE BLADDER. THE STONE WAS ABLE TO BE RETRIEVED. WHEN THE BASKET WAS PULLED OUT IT WAS FOUND THAT THE END OF THE BASKET WAS "FLIMSY." AS REPORTED, NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY AND 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 24886087 ↗
  • MalfunctionApr 6, 2026Break

    IT HAS BEEN REPORTED THAT THE BASKET OF A NCIRCLE TIPLESS STONE EXTRACTOR BROKE DURING THE REMOVAL OF THE STONE FRAGMENT DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE OF THE LEFT KIDNEY. ANOTHER SAME TYPE OF DEVICE WAS USED TO SUCCESSFULLY 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 24790840 ↗
  • MalfunctionMar 31, 2026Material Deformation

    IT WAS REPORTED THE BASKET WIRES OF AN NCIRCLE TIPLESS STONE EXTRACTOR LOST SHAPE DURING AN UNSPECIFIED PROCEDURE. THE CASE WAS BILATERAL, AND THE DEVICE FUNCTIONED AS EXPECTED ON THE FIRST SIDE BY SUCCESSFULLY CAPTURING AND EXTRACTING ALL STONE FRAGMENTS IN A SINGLE ATTEMPT. HOWEVER, ON THE SECOND SIDE, THE PRONGS OF THE BASKET FAILED TO MAINTAIN THE INTENDED 90-DEGREE SEPARATION UPON CLOSURE; INSTEAD, THEY SLID DOWNWARD TO APPROXIMATELY 10 DEGREES OF SEPARATION. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE; HOWEVER, IT REQUIRED APPROXIMATELY A DOZEN ATTEMPTS TO CAPTURE THE FRAGMENT. IT WAS REPORTED THE LOSS OF SHAPE INCREASED THE PROCEDURE TIME BY A FEW MINUTES. 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 24742361 ↗
  • MalfunctionMar 20, 2026Loss of or Failure to Bond

    IT WAS REPORTED THAT THE PROXIMAL PORTION OF AN NCIRCLE TIPLESS STONE EXTRACTOR DETACHED DURING A TRANSURETHRAL LITHOTRIPSY (TUL). AFTER LASER LITHOTRIPSY OF THE URETERAL STONE, THE BASKET WAS USED FOR STONE EXTRACTION. AFTER ONE TO TWO RETRIEVAL ATTEMPTS, THE BASKET COULD NO LONGER BE OPENED OR CLOSED. UPON INSPECTION, IT WAS FOUND THAT THE 'PROXIMAL PORTION' OF THE BASKET HAD DETACHED. THE DEVICE WAS REPLACED WITH ANOTHER SAME-LIKE DEVICE 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 24654756 ↗
  • MalfunctionMar 9, 2026Break

    IT WAS REPORTED THAT THE BASKET TIP OF AN NCIRCLE TIPLESS STONE EXTRACTOR SEPARATED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE IN THE RIGHT KIDNEY. WHEN CHECKING THE OPEN AND CLOSE FUNCTION OF THE DEVICE PRIOR TO USE IN THE PATIENT, THE BASKET TIP SEPARATED. A NEW SIMILAR-LIKE 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 24544966 ↗
  • MalfunctionMar 2, 2026Difficult to Open or Close

    IT WAS REPORTED, DURING A FLEXIBLE URETEROSCOPY, THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR DID NOT OPEN CORRECTLY. NO DAMAGE TO THE DEVICE WAS REPORTED. THE ISSUE WAS DISCOVERED WHILE TESTING THE DEVICE, PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER 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 24483091 ↗
  • MalfunctionFeb 24, 2026Break

    IT WAS REPORTED ONE OF THE BASKET WIRES AT THE LOOP OF AN NCIRCLE TIPLESS STONE EXTRACTOR BROKE WHEN FRAGMENTING A CALCULUS DURING A FLEXIBLE URETERUS PROCEDURE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24428901 ↗
  • MalfunctionFeb 23, 2026Loss of or Failure to Bond

    IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR¿S BASKET WIRE "BROKE" AND BASKET CANNOT BE PUSHED OUT PRIOR TO USE AN UNSPECIFIED KIDNEY PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. A CUSTOMER ATTACHED PHOTO APPEARS TO SHOW PART OF ONE OF THE BASKET WIRES. THIS IS SEPARATED FROM THE DISTAL NOTCHED CANNULA. THE SMALL LOOP THAT JOINS THE TWO BASKET WIRES IS VISIBLE AT THE DISTAL TIP OF THE BASKET SHEATH INDICATING ONE OF THE BASKET LOOPS MAY STILL BE IN THE SHEATH. 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 24414413 ↗
  • MalfunctionFeb 17, 2026Break

    IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR¿S BASKET "MESH" BROKE DURING THE URETERORENOLITHOTRIPSY PROCEDURE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24367687 ↗
  • MalfunctionFeb 13, 2026Break

    IT WAS REPORTED THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR BROKE DURING A RIGHT URETEROSCOPY PROCEDURE. THE DEVICE BROKE INSIDE OF THE PATIENT UPON THE FIRST ATTEMPT TO REMOVE A SMALL URETERAL STONE. ALL FRAGMENTS WERE RETRIEVED USING A URETERAL GRASPER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. THE BASKET WAS USED ONCE. THE SIZE OF THE STONE IS UNKNOWN. THE LASER WAS NOT USED AT THAT TIME. 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 24333798 ↗
  • MalfunctionFeb 9, 2026Loss of or Failure to Bond

    IT WAS REPORTED, DURING TRANSURETHRAL FLEXIBLE URETEROSCOPIC LITHOTRIPSY, THE BASKET TIP OF AN NCIRCLE TIPLESS STONE EXTRACTOR BROKE. THE EXTRACTOR WAS TESTED PRIOR TO USE AND FUNCTIONED NORMALLY. AFTER APPROXIMATELY 5 OR 6 STONES WERE REMOVED, THE BASKET TIP BROKE DURING A STONE RETRIEVAL, RENDERING THE DEVICE UNUSABLE. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW A BASKET WIRE PULLED FREE FROM BASKET CANNULA. 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 24297580 ↗
  • MalfunctionJan 29, 2026Difficult to Open or Close

    IT WAS REPORTED THAT THE BASKET DIAMETER OF AN NCIRCLE TIPLESS STONE EXTRACTOR BECAME SMALLER IN THE OPEN POSITION AFTER REMOVING STONES ABOUT 8 TO 10 TIMES MAKING IT UNABLE TO MEET THE REQUIREMENTS FOR STONE REMOVAL DURING A TRANSURETHRAL URETEROSCOPY LITHOTRIPSY PROCEDURE. THE DEVICE WAS REPLACED WITH 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 24215819 ↗
  • MalfunctionJan 15, 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 24084873 ↗
  • MalfunctionJan 15, 2026Difficult 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 24083014 ↗
  • MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, TWO NCIRCLE TIPLESS STONE EXTRACTORS (REFERENCE THIS REPORT) FAILED TO FULLY CLOSE WHILE THE SURGEON WAS EXTRACTING STONES FROM A PATIENT´S KIDNEY. THE SURGEON THEN CHANGED TO A THIRD SAME DEVICE, OF A DIFFERENT LOT, (REFERENCE PATIENT IDENTIFIER (B)(6) AND THE THIRD ONE ALSO FAILED. THE SURGEON THEN OPENED AN EQUIVALENT DEVICE FROM A DIFFERENT MANUFACTURER 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 HAS BEEN REQUESTED, HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23832135 ↗
  • MalfunctionDec 9, 2025Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

    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 23764896 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.