NCircleRecalls & reported problems across all models
Cook Incorporated · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 725
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls
- 0
We found 10 models of NCircle by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 725 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2015 and Sep 29, 2026 — classified as 43 injuries, 682 malfunctions.
The most frequently reported specific device problem is “Break” (288 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NCircle problems
Device problems
- Break288
- Difficult to Open or Close232
- Material Separation55
- Loss of or Failure to Bond50
- Device Operates Differently Than Expected44
- Material Deformation31
- Detachment of Device or Device Component19
- Device Damaged Prior to Use19
Patient problems
- No Consequences Or Impact To Patient299
- No Clinical Signs, Symptoms or Conditions232
- No Known Impact Or Consequence To Patient100
- No Patient Involvement62
- No Information14
- Device Embedded In Tissue or Plaque12
- Foreign Body In Patient11
- No Code Available8
NCircle models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NCircle G18778DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NCircle G19110DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- NCircle G17627DISLODGER, STONE, BASKET, URETERAL, METAL35 reports
- NCircle G18777DISLODGER, STONE, BASKET, URETERAL, METAL21 reports
- NCircle G23797Laparoscope, general & plastic surgery14 reports
- NCircle G17872DISLODGER, STONE, BASKET, URETERAL, METAL7 reports
- NCircle G19111DISLODGER, STONE, BASKET, URETERAL, METAL7 reports
- NCircle G18191DISLODGER, STONE, BASKET, URETERAL, METAL1 report
Recent NCircle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938865 ↗MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938712 ↗MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931223 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond
It was reported that during Retrograde Intrarenal Surgery (RIRS), the mesh of an NCIRCLE TIPLESS STONE EXTRACTOR was found to be broken and unusable upon initial product testing. The surgeon immediately replaced it with a new unit to successfully complete the surgery. A photo was provided that appears to show a basket wire separated from the distal notched cannula.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 50927279 ↗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 ↗MalfunctionAug 13, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241541 ↗MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237770 ↗MalfunctionAug 13, 2026Break; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237768 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210247 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209379 ↗MalfunctionAug 11, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208063 ↗MalfunctionAug 11, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207389 ↗MalfunctionAug 10, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193530 ↗MalfunctionAug 7, 2026Difficult to Open or Close
It was reported that a loss of function was identified on a Cook NCircle Tipless Stone Extractor. The user tested the device before use and discovered "the basket cannot be pushed out." The device was not used, and 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 50182609 ↗MalfunctionAug 7, 2026Loss of or Failure to Bond
It was reported, during a Ureteroscopy, the tip of an NCircle Tipless Stone Extractor was found broken.The issue was discovered prior to patient contact, when the device was removed from its product packaging. Preliminary evaluation of the returned device appears to show a basket wire has pulled out of the distal cannula. 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 50181244 ↗
Other Cook Incorporated products
- Torcon NB79 models · 36 reports · 68 recalls
- Flexor134 models · 1,437 reports · 3 recalls
- Instinct5 models · 1,289 reports · 1 recall
- Saeed15 models · 863 reports
- Advance206 models · 816 reports
- Gunther Tulip5 models · 807 reports
- Hemospray2 models · 535 reports · 4 recalls
- Roadrunner28 models · 183 reports · 9 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page