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NCircle G19111Recalls & reported problems

Cook Incorporated · NCircle, Nitinol Tipless Stone Extractor Modified Delta Wire, Basket · Class 2

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002191112), received between Nov 8, 2017 and Jul 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Open or Close5
  • Bent2

Patient problems

  • No Consequences Or Impact To Patient5
  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 29, 2026Difficult to Open or Close

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50069325 ↗
  • MalfunctionJun 13, 2019Difficult to Open or Close; Difficult to Open or Close

    IT IS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY USING A NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR, THE BASKET WOULD NOT OPEN. PRIOR TO THE PROCEDURE, THE BASKET WAS PRE-TESTED AND CONFIRMED TO FUNCTION PROPERLY. THE PHYSICIAN THEN INTRODUCED THE COMPLAINT DEVICE DOWN THE SCOPE AND AS HE ATTEMPTED TO OPEN THE BASKET, IT WOULD NOT OPEN. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED MALFUNCTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8697510 ↗
  • MalfunctionMar 12, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BASKET WOULD NOT CLOSE WHEN DEPLOYED. ANOTHER BASKET WAS OPENED TO USE IN ITS PLACE. THERE WERE NO ADVERSE CONSEQUENCES OR EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7330186 ↗
  • MalfunctionFeb 21, 2018Bent; Bent

    IT WAS REPORTED THAT THE WIRES OF THE BASKET OF THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BECAME BENT AND MISSHAPEN DURING USAGE AND MULTIPLE PASSES OF THE BASKET USING A FLEXIBLE CYSTOSCOPE. A NEW BASKET WAS USED AFTER THIS OCCURRED TO COMPLETE THE PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. IT HAS BEEN REPORTED THAT NO UNINTENDED PORTION OF THE DEVICE DETACHED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7286128 ↗
  • MalfunctionFeb 21, 2018Bent; Bent

    IT WAS REPORTED THAT THE WIRES OF THE BASKET OF THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WERE NOTED TO BE BENT AND MISSHAPEN UPON OPENING AND BEFORE USE. THEN THIS DEVICE WAS USED TO COMPLETE THE PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. IT HAS BEEN REPORTED THAT NO UNINTENDED PORTION OF THE DEVICE DETACHED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7286092 ↗
  • MalfunctionJan 16, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED PRIOR TO PATIENT CONTACT, THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BASKET WAS NOT OPENING. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Patient Involvement

    MAUDE report 7192881 ↗
  • MalfunctionNov 8, 2017Difficult to Open or Close; Difficult to Open or Close

    THE USER FACILITY REPORTED THAT THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR BASKET WOULD NOT OPEN PRIOR TO USE ON THE PATIENT. THERE WAS NO PATIENT CONTACT WITH THIS DEVICE. THERE WERE NO ADVERSE CONSEQUENCES OR EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT AND EVENT INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7008743 ↗

Other DISLODGER, STONE, BASKET, URETERAL, METAL devices

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