NCircle G17520Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00827002175204), received between Jan 26, 2017 and Sep 29, 2026 — classified as 129 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 129 reports, 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 ↗
• 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, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208063 ↗
• 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 ↗
• MalfunctionJun 22, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE NCIRCLE TIPLESS STONE EXTRACTOR WAS UNABLE TO RETRIEVE STONES PRIOR TO THE STONE REMOVAL PROCEDURE IN THE COMMON BILE DUCT. THE PRODUCT WAS FOUND BROKEN BEFORE USE AND WAS IMMEDIATELY REPLACED. A PRELIMINARY REVIEW OF THE RETURNED DEVICE APPEARS TO SHOW ONE WIRE PULLED FREE FROM BASKET FORMATION. 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 25581291 ↗
• MalfunctionJun 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, AN NCIRCLE TIPLESS STONE EXTRACTOR CONTAINED FOREIGN MATTER INSIDE THE UNOPENED PACKAGE. THE DEVICE WAS NOT USED AND WAS REPLACED WITH ANOTHER SAME-TYPE DEVICE 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 25364645 ↗
• MalfunctionMay 29, 2026Loss of or Failure to Bond

  IT WAS REPORTED PRIOR TO AN URETEROSCOPIC LITHOTRIPSY FOR STONE REMOVAL PROCEDURE, THE USER FOUND ONE NCIRCLE TIPLESS STONE EXTRACTOR'S BASKET WIRE "BROKEN" (COVERED IN PATIENT IDENTIFIER (B)(6)) AND THE SHEATH "BROKEN" AT THE JUNCTION WITH THE HANDLE ASSEMBLY (COVERED IN PATIENT IDENTIFIER (B)(6)). THE PROCEDURE WAS COMPLETED BY USING A NEW UNSPECIFIED "BASKET". 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 25333445 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED PRIOR TO AN URETEROSCOPIC LITHOTRIPSY FOR STONE REMOVAL PROCEDURE, THE USER FOUND ONE NCIRCLE TIPLESS STONE EXTRACTOR'S BASKET WIRE "BROKEN" (COVERED IN PATIENT IDENTIFIER: (B)(6) AND THE SHEATH "BROKEN" AT THE JUNCTION WITH THE HANDLE ASSEMBLY (COVERED IN PATIENT IDENTIFIER: (B)(6). THE PROCEDURE WAS COMPLETED BY USING A NEW UNSPECIFIED "BASKET". 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 25219997 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED, DURING A STONE REMOVAL IN THE UPPER SEGMENT OF LEFT URETER, AN NCIRCLE TIPLESS STONE EXTRACTOR WAS FOUND TO BE SOMEWHAT "SLUGGISH" DURING TESTING. ANOTHER BASKET WAS USED TO COMPLETE THE PROCEDURE. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW THE CANNULA PROTRUDING THROUGH THE COLLET KNOB. 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 24971828 ↗
• MalfunctionApr 22, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE FRONT SECTION OF AN NCIRCLE TIPLESS STONE EXTRACTOR BASKET WAS FOUND TO BE BROKEN UPON REMOVAL FROM THE INTACT PACKAGING. A NEW DEVICE WAS OPENED TO COMPLETE THE 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

  MAUDE report 24954662 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THE CONNECTION BETWEEN THE HANDLE AND THE CATHETER BROKE OF THE NCIRCLE TIPLESS STONE EXTRACTOR DURING A BLADDER LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW 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 24812026 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THE HANDLE CONJUNCTION AREA SURFACE OF AN NCIRCLE TIPLESS STONE EXTRACTOR WAS BROKEN PRIOR TO USE DURING AN URETERAL STONE SURGERY PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 24742601 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED, DURING A COMMON BILE DUCT EXPLORATION AND T-TUBE DRAINAGE PROCEDURE, THE OUTER SKIN NEAR THE HANDLE OF AN NCIRCLE TIPLESS STONE EXTRACTOR SUDDENLY BROKE. THE DEVICE WAS IMMEDIATELY REPLACED, THE SURGERY PROCEEDED SMOOTHLY, AND THE PATIENT'S SAFETY WAS NOT AFFECTED. 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 24714311 ↗
• MalfunctionMar 17, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE "PLASTIC HEAD" OF AN NCIRCLE TIPLESS STONE EXTRACTOR HANDLE DETACHED DURING AN UNSPECIFIED PROCEDURE IN THE KIDNEY. THE DEVICE WAS REPLACED WITH A NEW DEVICE 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 24620824 ↗
• MalfunctionMar 10, 2026Break

  AS REPORTED, THE OUTER SKIN OF THE NCIRCLE TIPLESS STONE EXTRACTOR'S STONE RETRIEVAL BASKET BROKE WHEN CLOSING THE BASKET DURING A COMMON BILE DUCT STONE REMOVAL PROCEDURE. THE BASKET WAS DEEMED UNUSABLE AND WAS REPLACED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE FAILURE INCREASED THE PROCEDURE COSTS AND PROLONGED THE DURATION OF THE PROCEDURE FOR THE PATIENT. 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 24559810 ↗
• MalfunctionFeb 19, 2026Material Deformation

  IT WAS REPORTED THAT THE NCIRCLE TIPLESS STONE EXTRACTOR¿S BASKET WAS UNABLE TO OPEN AND CLOSE PROPERLY DURING BLADDER LITHOTRIPSY PROCEDURE. THE DEVICE DID NOT SUCCESSFULLY REMOVE THE STONE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. A CUSTOMER ATTACHED PHOTO NOTED ONE OF THE BASKET WIRES WAS BENT. 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 24388190 ↗
• MalfunctionFeb 17, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE BASKET OF AN NCIRCLE TIPLESS STONE EXTRACTOR BROKE AND COULD NOT BE USED TO REMOVE THE STONE DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. THE USER CHANGED TO SIMILAR-LIKE DEVICE TO COMPLETE THE PROCEDURE. AN IMAGE WAS PROVIDED BY THE CUSTOMER DETAILING THE WIRES OF THE BASKET 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 24367345 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED, THE BASKET WIRE OF ONE NCIRCLE TIPLESS STONE EXTRACTOR BROKE AND SPLIT DURING AN UNSPECIFIED PROCEDURE. THE ISSUE WAS DETECTED BEFORE USE. A LASER WAS USED AT THE SAME TIME AS THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A 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 24334306 ↗
• MalfunctionFeb 13, 2026Loss of or Failure to Bond

  IT WAS REPORTED, DURING STONE REMOVAL IN THE BLADDER, THE BASKET WIRES OF TWO NCIRCLE TIPLESS STONE EXTRACTORS BROKE. BOTH BASKET WIRES BROKE AFTER CAPTURING A STONE AND ATTEMPTING TO REMOVE IT. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW A BASKET WIRE PULLED FREE FROM BASKET CANNULA IN BOTH DEVICES. 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. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334006 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT THE SHEATH OF ON NCIRCLE TIPLESS STONE EXTRACTOR BROKE PRIOR TO USE DURING A BLADDER STONE REMOVAL PROCEDURE. UPON OPENING THE INNER PACKAGING OF THE BASKET, A CREASE WAS NOTED TO BE NEAR THE HANDLE MAKING THE BASKET IMPOSSIBLE TO OPEN. UPON FURTHER INSPECTION, THE SHEATH NEAR THE HANDLE WAS DISCOVERED TO BE BROKEN. THE DEVICE WAS REPLACED WITH A NEW BASKET, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 24317196 ↗
• MalfunctionFeb 9, 2026Break

  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 24293651 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HANDLE AND BASKET CONJUNCTION AREA OF AN NCIRCLE TIPLESS STONE EXTRACTOR BROKE. A PHOTO WAS PROVIDED AND APPEARS TO SHOW THE SUPPORT SHEATH BROKE NEAR THE HANDLE. 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 24257304 ↗