NCircle G46206Recalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 00827002462069), received between Mar 19, 2015 and Sep 29, 2026 — classified as 6 injuries, 191 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (78 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209379 ↗
• 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 ↗
• MalfunctionMay 28, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE NCIRCLE TIPLESS STONE EXTRACTOR COULD BE OPENED AND CLOSED APPROXIMATELY TWICE, BUT AFTER THAT IT BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME SPECIFICATIONS. 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 25323386 ↗
• MalfunctionMay 28, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF AN NCIRCLE TIPLESS STONE EXTRACTOR, THE WIRE OF THE EXTRACTOR WAS OBSERVED TO BE BROKEN PRIOR TO USE. THE USER REPLACED THE DEVICE WITH A NEW SIMILAR-LIKE DEVICE TO COMPLETE THE URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE WITHOUT DIFFICULTIES. 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 25321960 ↗
• MalfunctionMay 7, 2026Difficult to Open or Close

  IT WAS REPORTED "THE WIRE IN THE HANDLE PORTION PROTRUDED FROM THE GROOVE" OF THE NCIRCLE TIPLESS STONE EXTRACTOR DURING A TRANSURETHRAL URETEROSCOPIC LITHOTRIPSY PROCEDURE WHILE USED WITH A URETEROSCOPE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-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 25117061 ↗
• MalfunctionMay 5, 2026Break

  AS REPORTED, UPON OPENING THE PACKAGE OF AN NCIRCLE TIPLESS STONE EXTRACTOR, THE USER FOUND ONE LINE OF THE BASKET WIRE TO BE BROKEN. THE URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE WAS COMPLETED WITHOUT DIFFICULTIES BY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078785 ↗
• MalfunctionMar 24, 2026Break; Difficult to Open or Close

  AS REPORTED, THE TIP OF A NCIRCLE TIPLESS STONE EXTRACTOR BROKE, RENDERING IT IMPOSSIBLE TO DEPLOY THE EXTRACTOR TO CAPTURE KIDNEY STONES DURING AN UNKNOWN PROCEDURE. A SECOND EXTRACTOR WAS OPENED TO CONTINUE AND COMPLETE THE PROCEDURE. THERE HAVE BEEN NO REPORT OF A PATIENT EXPERIENCING ADVERSE EFFECTS OR REQUIRING ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24675477 ↗
• MalfunctionMar 24, 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 24675162 ↗
• MalfunctionMar 17, 2026Difficult to Open or Close

  IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR WAS UNABLE TO OPEN COMPLETELY PRIOR TO AN UNSPECIFIED PROCEDURE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615912 ↗
• MalfunctionMar 11, 2026Material Deformation

  IT WAS REPORTED, DURING TRANSURETHRAL URETEROLITHOTRIPSY, THE NCIRCLE TIPLESS STONE EXTRACTOR WAS UNABLE TO GRASP THE STONE AFTER ONE OR TWO SUCCESSFUL RETRIEVALS OF FRAGMENTED CALCULI. THE PROCEDURE WAS PERFORMED UNDER FLEXIBLE URETEROSCOPY FOR RENAL AND URETERAL STONES. WHEN THE DEVICE COULD NO LONGER GRASP THE STONE, THE REMAINING FRAGMENTS WERE SUCCESSFULLY REMOVED USING ANOTHER DEVICE OF THE SAME TYPE. 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 24567236 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR WAS DAMAGE-BROKEN PRIOR TO AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED. 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. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE COMPLAINT WAS ORIGINALLY NOT REPORTABLE DUE TO LACK OF INFORMATION. HOWEVER, COMPLAINT BECOME REPORTABLE FOLLOWING DEVICE EVALUATION AND INVESTIGATION COMPLETION.

  Patient problems: Insufficient Information

  MAUDE report 24511593 ↗
• MalfunctionMar 4, 2026Break; Difficult to Open or Close

  IT WAS REPORTED THAT THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR WOULD NOT DEPLOY NOR OPEN NORMALLY PRIOR TO USE DURING AN URETEROSCOPY WITH LASER LITHOTRIPSY (URSL) PROCEDURE. THE COMPLAINT DEVICE WAS REPLACED WITH A NEW SIMILAR-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER DIFFICULTIES. 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 24509497 ↗
• MalfunctionFeb 25, 2026Loss of or Failure to Bond

  IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR¿S BASKET WIRE BROKE DURING A TRANSURETHRAL URETEROLITHOTRIPSY PROCEDURE. THE DEVICE WAS USED TO REMOVE A 3MM STONE. A SECOND STONE WAS ABLE TO BE REMOVED AND THE ISSUE WAS DISCOVERED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. THE COMPLAINT DEVICE WAS INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAD OCCURRED. THE BASKET WAS TESTED IN THE UNCOILED POSITION PRIOR TO USE AND FUNCTIONED PROPERLY. A LASER WAS NOT USED WHILE THE BASKET WAS USED. NO PART OF THE DEVICE SEPARATED. THERE WAS NOTHING WITH THE PATIENT¿S ANATOMY KEEPING THE BASKET FROM OPENING OR CLOSING. 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 24442900 ↗
• MalfunctionFeb 17, 2026Break; Difficult to Open or Close

  IT WAS REPORTED THAT THE NCIRCLE TIPLESS STONE EXTRACTOR¿S HANDLE WAS STIFF AND WAS UNABLE TO FUNCTION DURING A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE. THE DEVICE WAS INSERTED INTO THE SCOPE CHANNEL. WHEN ATTEMPTING TO OPEN AND CLOSE THE BASKET, THE HANDLE WAS STIFF AND DIFFICULT TO OPERATE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. THE STONE WAS LOCATED IN THE URINARY TRACT. IT IS UNKNOWN IF THE BASKET WAS TESTED PRIOR TO USE. NO PART OF THE DEVICE SEPARATED IN THE PATIENT. THE PATIENT¿S ANATOMY WAS NOT KEEPING THE BASKET FROM OPENING OR CLOSING. 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 24365165 ↗
• MalfunctionFeb 9, 2026Break; Material Deformation

  IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR¿S BASKET WAS DEFORMED DURING A TRANSURETHRAL URINARY STONE REMOVAL PROCEDURE, MAKING IT DIFFICULT TO EXTRACT THE CALCULUS. THE CALCULUS WAS PREVIOUSLY FRAGMENTED USING A LASER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298926 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED, THE WIRE OF AN NCIRLCE TIPLESS STONE EXTRACTOR BROKE DURING A TRANS URETERAL LITHOTRIPSY (TUL) ENDOSCOPIC PROCEDURE FOR URETERAL STONES FOLLOWED BY STONE RETRIEVAL. DURING USE, THE WIRE OF THE BASKET BOKE AFTER GRASPING A URETERAL STONE AND CLOSING THE BASKET. THE DEVICE WAS THEREFORE NOT USED FURTHER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE DEVICE WAS TESTED PRIOR TO USE AND NO ISSUES WERE OBSERVED. DURING THE INITIAL ATTEMPT, NO EXCESSIVE MANIPULATION, ANGULATION, OR FORCE WAS USED. 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 24298255 ↗
• MalfunctionFeb 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE HANDLE OF AN NCIRCLE TIPLESS STONE EXTRACTOR WAS DAMAGED. AFTER OPENING THE PACKAGE AND PRIOR TO USE, A FUNCTIONAL TEST WAS CONDUCTED AND THE HANDLE WAS FOUND TO BE DAMAGED. PER PROVIDED CUSTOMER PHOTOS, THE METAL CANNULATED HANDLE COMPONENT WAS BENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-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 24296158 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED AFTER ADVANCING THE NCIRCLE TIPLESS STONE EXTRACTOR INTO THE URETER AND ATTEMPTING TO PLACE THE STONE IN THE BASKET, THE PHYSICIAN FOUND THAT THE BASKET WIRE HAD SEVERED. THE COMPLAINT DEVICE WAS REPLACED WITH A NEW SAME-LIKE DEVICE (LOT UNKNOWN) TO COMPLETE THE PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE AND WAS UNDAMAGED. THE DEVICE WAS TESTED IN ITS UNCOILED POSITION AND THE BASKET OPERATED CORRECTLY. NO LASER WAS USED DURING BASKET OPERATION, AND THERE WERE NO ANATOMICAL ISSUES PREVENTING THE BASKET FROM OPENING OR CLOSING. THE HANDLE WAS NOT POSITIONED STRAIGHT TOWARD THE PATIENT OR POINTED AT THE CEILING. NO PARTS SEPARATED. THE PATIENT WAS UNDER ANESTHESIA. 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 24027624 ↗
• MalfunctionDec 5, 2025Break; Break

  AS REPORTED, DURING A TRANSURETHRAL UROLITHOTRIPSY PROCEDURE, AN NCIRCLE TIPLESS STONE EXTRACTOR WAS USED TO RETRIEVE A STONE. AFTER OPENING THE PRODUCT, A TEST OPERATION WAS PERFORMED, AND NO PROBLEMS WERE OBSERVED. WHEN ATTEMPTING TO GRASP THE STONE, THE DEVICE WAS UNABLE TO DO SO ON THE FIRST ATTEMPT. UPON REMOVAL AND INSPECTION, IT WAS FOUND THAT THE BASE OF THE BASKET HAD SEVERED. THE WIRE HAD BROKEN OFF, DESPITE NO EXCESSIVE FORCE BEING APPLIED DURING USE. ANOTHER NCIRCLE TIPLESS STONE EXTRACTOR FROM A DIFFERENT LOT WAS UTILIZED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THERE WERE NO CONCERNS REGARDING DEVICE HANDLING AT THE FACILITY OR BY THE PHYSICIANS, WHO ARE EXPERIENCED WITH THIS PRODUCT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729669 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR BROKEN DURING AN UNSPECIFIED PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687841 ↗
• MalfunctionNov 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED DURING A TRANSURETHAL LITHOTRIPSY (TUL) PROCEDURE, THE STONE WAS FRAGMENTED USING A LASER AND ONE FRAGMENT WAS RETRIEVED USING A NCIRCLE TIPLESS STONE EXTRACTOR, BUT THE BASKET THEN BECAME UNABLE TO BE OPENED OR CLOSED. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23630155 ↗
• MalfunctionNov 19, 2025Break; Break

  AS REPORTED, PRIOR TO AN URETEROSCOPY LITHOTRIPSY (URSL) PROCEDURE, THE USER OPENED THE PACKAGE OF AN 'NCIRCLE TIPLESS STONE EXTRACTOR' AND FOUND THAT ONE END OF THE BASKET WIRE WAS PULLED FREE FROM THE BASKET CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTIES BY USING ANOTHER 'NCIRCLE TIPLESS STONE EXTRACTOR'. 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 23597529 ↗
• MalfunctionNov 12, 2025Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED, AN NCIRCLE TIPLESS STONE EXTRACTOR¿S OUTER SUPPORT SHEATH KINKED NEAR THE HANDLE ON THE PROTECTION SHEATH. THE DEVICE WAS UNABLE TO OPEN AND CLOSE DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE WHILE ATTEMPTING TO REMOVE A RENAL STONE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER UNSPECIFIED DEVICE. IT IS UNKNOWN WHETHER THE DEVICE WAS INSPECTED BEFORE USE, TESTED IN DIFFERENT POSITIONS, FUNCTIONED PROPERLY, USED WITH A SCOPE, THE SCOPE¿S CHANNEL SIZE, STONE SIZE, LASER USAGE, PATIENT ANATOMY IMPACT, USE OF OTHER DEVICES, DEVICE ORIENTATION, NUMBER OF STONES CAPTURED BEFORE FAILURE, ANY PART SEPARATION, OR IF THE PATIENT WAS UNDER ANESTHESIA. 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 23533574 ↗
• MalfunctionNov 5, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  ADDITIONAL INFORMATION WAS RECEIVED 29OCT2025. INITIALLY, THE BASKET WAS STIFF AND DID NOT OPEN OR CLOSE SMOOTHLY. AFTER ATTEMPTING TO OPEN AND CLOSE THE DEVICE ABOUT FIVE TIMES, THE BASKET SHEATH SEVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479630 ↗