NCircle G18777Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002187771), received between Feb 26, 2016 and Apr 3, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Material Deformation

  IT WAS REPORTED THAT THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR WAS DIFFICULT TO OPEN AND CLOSE MAKING IT UNABLE TO PROPERLY REMOVE STONES PRIOR TO USE DURING AN URETEROSCOPIC LITHOTRIPSY, INTRARENAL STONE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING THE SAME-TYPE DEVICE. PER PROVIDED CUSTOMER IMAGE, THE BASKET APPEARS TO BE MISSHAPED. 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 24778129 ↗
• InjuryNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE WIRE OF AN 'NCIRCLE TIPLESS STONE EXTRACTOR' DETACHED. AS REPORTED, THE SURGEON ATTEMPTED TO RETRIEVE A STONE MEASURING APPROXIMATELY 5¿7 MM FROM THE MID-TO-LOWER URETER USING THE DEVICE; HOWEVER, THE STONE WAS DETERMINED TO BE TOO LARGE. THE USER THEN ATTEMPTED TO FRAGMENT THE STONE WITH A LASER, AND DURING THIS PROCESS, THE LASER CONTACTED ONE OF THE BASKET WIRES. AS A RESULT, THE WIRE DETACHED FROM ONE END WHILE THE OPPOSITE END REMAINED ATTACHED TO THE MAIN BODY OF THE DEVICE. IT WAS REPORTED THAT UPON REMOVAL OF THE DEVICE 'LATER ON', IT WAS NOTED THAT THE OTHER END OF THE WIRE HAD ALSO SEPARATED FROM THE DEVICE AND COULD NOT BE LOCATED. ANOTHER EXTRACTOR WAS SUBSEQUENTLY USED TO RETRIEVE ALL REMAINING STONE FRAGMENTS. THE PATIENT WILL UNDERGO A COMPUTED TOMOGRAPHY (CT) SCAN TO ASSESS IF A PORTION OF THE WIRE REMAIN INSIDE THE BODY; RESULTS ARE UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23532945 ↗
• MalfunctionSep 9, 2025Break; Material Deformation; Break; Material Deformation

  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 23008126 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED, DURING A FLEXIBLE URETEROSCOPY WITH LITHOTRIPSY STONE REMOVAL PROCEDURE, WHEN THE USER OPENED THE PACKAGE AND TOOK OUT THE NCIRCLE TIPLESS STONE EXTRACTOR IT WAS FOUND THE BASKET TIP WAS BROKEN. THE USER CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. THE CUSTOMER PROVIDED A PICTURE THAT APPEARS TO SHOW THE BASKET IS MISSING A SECTION OF WIRE. 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 22955039 ↗
• MalfunctionMay 7, 2025Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED THAT THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR COULD NOT BE OPENED DURING A URETERAL LITHOTRIPSY PROCEDURE WITH FLEXIBLE ENDOSCOPE. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT. THE USER ATTEMPTED TO OPEN THE BASKET BY PUSHING THE HANDLE AND FOUND THEM BROKEN. A TOTAL OF 2 DEVICES FROM THE SAME LOT EXPERIENCED THIS ISSUE. THE PROCEDURE WAS COMPLETED WHEN THE USER CHANGED TO A THIRD SAME TYPE DEVICE. IMAGES OF PRODUCT WERE ATTACHED OF WHAT APPEARS TO SHOW BASKET NOT OPEN, BROKEN AT THE HANDLE 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 21979947 ↗
• MalfunctionMar 19, 2025Break; 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 21648898 ↗
• MalfunctionMar 13, 2025Loss of or Failure to Bond; Difficult to Open or Close; Loss of or Failure to Bond; Difficult to Open or Close

  IT WAS REPORTED, DURING AN URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, ON THE 3RD PASS, THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR, WENT IN AND OUT OF THE SCOPE WITH A STONE, AND THE WIRE THAT CONNECTS TO THE BASKET, DETACHED/BROKE OFF FROM THE HANDLE, RENDERING THE PRODUCT USELESS. IT WAS USED FOR MAYBE 30 SECONDS BEFORE IT BROKE. USE OF THE DEVICE WAS DISCONTINUED. THE REP ASSUMED, THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME TYPE DEVICE. 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 21599591 ↗
• MalfunctionFeb 20, 2025Break; 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 21423484 ↗
• MalfunctionFeb 10, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR¿S WIRE APPEARED TO BE OUT OF THE BASKET PRIOR TO PATIENT CONTACT DURING AN UNSPECIFIED PROCEDURE. A SUPPLIED PHOTO APPEARED TO SHOW THE HANDLE AND SHEATH OF THE DEVICE WAS NOT BEING HELD IN PLACE IN THE CLEAR SHIPPING TRAY. THE POUCH WAS SEALED. NO ADDITIONAL PHOTOS ARE AVAILABLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349166 ↗
• MalfunctionJan 29, 2019Material Separation; Material Separation

  IT WAS REPORTED, THE SURGEON MAY HAVE PULLED A LITTLE TOO HARD BUT THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET BROKE TODAY WHEN HE WAS PULLING A 1.2CM KIDNEY STONE OUT DURING A PERCUTANEOUS NEPHROLITHOTOMY PCNL PROCEDURE. HALF OF THE BASKET PART (NITINOL WIRE) DID SEPARATE BUT IT WAS RETRIEVED BY A FLEXIBLE GRASPER. ALL PIECES (2) ARE BELIEVED TO HAVE COME OUT. THEY WERE USING A KARL STORZ FLEXIBLE NEPHROSCOPE WITH A 7FR INNER DIAMETER. AS REPORTED, NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED AND THERE WERE ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285249 ↗
• MalfunctionJan 22, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8267965 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED, DURING A URETEROSCOPY, THE NCIRCLE TIPLESS STONE EXTRACTOR WAS FOUND BENT IN THE PACKAGING, BROKEN OFF AT HANDLE. ANOTHER DEVICE WAS OPENED AND PROCEDURE WAS COMPLETED AS NORMAL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085554 ↗
• MalfunctionJul 16, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED, DURING A NEPHROLITHOTRIPSY, THE BASKET OF THE NCIRCLE TIPLESS STONE EXTRACTOR DIDN'T´T OPEN. A NEW EXTRACTOR WAS USED TO FINISH THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689680 ↗
• InjuryMar 26, 2018Material Separation; Material Separation

  IT WAS REPORTED THE TIP OF A NCIRCLE TIPLESS STONE EXTRACTOR BROKE DURING AN URS PROCEDURE. THE DEVICE WAS REMOVED AND FORCEPS WERE USED TO RETRIEVE THE DETACHED TIP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE AS INTENDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7370127 ↗
• MalfunctionNov 30, 2017Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY REPORTED DURING A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE, THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET WOULD NOT GRAB PATIENT'S STONE. IT WAS STATED THE HEAD OF THE BASKET WAS DEFECTIVE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070167 ↗
• MalfunctionOct 10, 2017Break; Break

  THE AREA REPRESENTATIVE REPORTED A CYSTOURETHROSCOPY AND LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. AS REPORTED, THE BASKET OF THE NCIRCLE TIPLESS STONE EXTRACTOR BROKE WHILE IT WAS BEING USED. A SECOND NCIRCLE TIPLESS STONE EXTRACTOR WAS OPENED AND IT ALSO BROKE DURING USE. AS REPORTED NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE BROKEN BASKETS. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT. ADDITIONAL EVENT AND PATIENT INFORMATION HAS BEEN REQUESTED. TWO MEDWATCH REPORTS HAVE BEEN FILED TO CAPTURE TWO DEVICES BREAKING DURING USE. MFR. REPORT # 1820334-2017-03512 CAPTURES THE FIRST EXTRACTOR BASKET BREAKAGE AND MFR. REPORT # 1820334-2017-03510 CAPTURES THE SECOND EXTRACTOR BASKET BREAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6935987 ↗
• MalfunctionSep 15, 2017Break; Break

  DURING THE PROCEDURE THE EXTRACTOR WAS BROKEN. THERE WAS NO OTHER INFORMATION PROVIDED BY THE REPORTER. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867975 ↗
• MalfunctionJun 9, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO PERFORMING A RETROGRADE INTRARENAL SURGERY (RIRS) ON A PATIENT, THE PHYSICIAN FOUND THAT THE TIP OF THE NCIRCLE TIPLESS STONE EXTRACTOR BASKET COULD NOT BE OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY USING ANOTHER NCIRCLE TIPLESS STONE EXTRACTOR.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6629408 ↗
• InjuryApr 26, 2017Kinked; Detachment of Device or Device Component; Device Dislodged or Dislocated; Kinked; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE AREA REPRESENTATIVE THAT A PATIENT UNDERWENT A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. THE DEVICE IN USE WAS AN NCIRCLE TIPLESS STONE EXTRACTOR. THE REPORT STATED THE BASKET BROKE DURING THE PROCEDURE. A PIECE OF THE BASKET WAS LODGED INTO THE STONE AND STILL REMAINS INSIDE THE PATIENT¿S KIDNEY. THE FACILITY ATTEMPTED TO RETRIEVE THE BROKEN PIECE WITH A GRASPER HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL AND A NEPHROSTOMY TUBE WAS INSERTED. THEY WERE ABLE TO EXTRACT THE REMAINING STONE BURDEN AND THE SMALL PIECE OF THE BASKET LEFT BEHIND. THERE WAS NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6522392 ↗
• MalfunctionMar 7, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO BASKETS FROM THE SAME LOT NUMBER THAT ONLY OPENED ON ONE SIDE. THEY WERE USED DURING DIFFERENT HOLMIUM LASER WITH LITHOTRIPSY PROCEDURES ON THE SAME DAY. ONLY ONE OF THE DEVICES IS AVAILABLE TO BE RETURNED. THERE WERE NO ADVERSE EFFECTS TO EITHER PATIENT REPORTED. THERE WAS NO FURTHER INFORMATION PROVIDED FOR EITHER PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6383492 ↗
• InjuryFeb 26, 2016Material Separation; Material Separation

  ACCORDING TO THE INITIAL REPORTER, THE BASKET RETRIEVAL BROKE OFF IN THE PATIENT. DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5464126 ↗