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
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
- 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
- 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.