Perc NCircle G32862Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00827002328624), received between Aug 22, 2016 and Apr 8, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FLAKES OF A FOREIGN MATERIAL SUBSTANCE WERE INSIDE THE UNOPENED STERILE PACKAGING OF A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR. A PRELIMINARY INVESTIGATION OF THE RETURN DEVICE SHOWS THERE WAS FOREIGN MATTER INSIDE THE SEALED PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815649 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR, WAS BROKEN AT THE JUNCTION WHERE THE SHAFT CONNECTS TO THE RED HANDLE. THE SHAFT WAS DISCONNECTED FROM THE HANDLE BUT NOT DETACHED. THE SURGEON ATTEMPTED TO RECONNECT THE DEVICE AND PROCEEDED WITH ITS USE. AFTER INSERTION INTO THE PATIENT, THE DEVICE FAILED TO OPEN/DEPLOY AND WAS UNABLE TO GRASP THE STONE. AS SUCH, THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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. MOREOVER, AS REPORTED, THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED, OR SCARRED ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595556 ↗
• MalfunctionJan 12, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED ON 02MAR2026. THE USER NOTICED THE BASKET WAS BENT WHEN THEY TOOK IT OUT OF THE PACKAGE. THEREFORE, THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BASKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037415 ↗
• MalfunctionOct 20, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), THE BASKET OF THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR "BROKE" WHEN EXTRACTING A STONE. THE BASKET "BROKE" WHILE THE PHYSICIAN WAS FORCEFULLY PULLING THE STONE THROUGH THE ACCESS SHEATH. THE PATIENT HAD SEVERAL LARGE STONES, BUT THE SIZE OF THE STONE BEING REMOVED IS UNKNOWN. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW THE BASKET WIRES SEPARATED FROM THE BASKET CANNULA. A SECOND NCIRCLE EXTRACTOR WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY, 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 23334693 ↗
• MalfunctionOct 10, 2025Difficult to Open or Close; Difficult to Open or Close

  CORRECTION: THREE EXTRACTORS WERE NOT ABLE TO OPEN AND CLOSE DURING THE SAME PROCEDURE FOR THE SAME PATIENT. ONE OF THE EXTRACTORS IS COVERED UNDER THIS REPORT WITH THE PATIENT IDENTIFIER 091076 AND MANUFACTURER REPORT NUMBER 1820334-2025-01229. THE OTHER TWO EXTRACTORS ARE COVERED UNDER THE MANUFACTURER REPORT NUMBER 1820334-2025-01224 AND 1820334-2025-01227. ADDITIONAL INFORMATION WAS RECEIVED 16DEC2025. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER EXTRACTOR THAT WAS FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270268 ↗
• MalfunctionOct 10, 2025Difficult to Open or Close; Difficult to Open or Close

  CORRECTION: THREE EXTRACTORS WERE NOT ABLE TO OPEN AND CLOSE DURING THE SAME PROCEDURE FOR THE SAME PATIENT. ONE OF THE EXTRACTORS IS COVERED UNDER THIS REPORT WITH THE PATIENT IDENTIFIER: (B)(6) AND MANUFACTURER REPORT NUMBER: 1820334-2025-01224. THE OTHER TWO EXTRACTORS ARE COVERED UNDER THE MANUFACTURER REPORT NUMBER: 1820334-2025-01229 AND 1820334-2025-01227. ADDITIONAL INFORMATION WAS RECEIVED 16DEC2025. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER EXTRACTOR THAT WAS FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270191 ↗
• MalfunctionAug 15, 2025Difficult to Open or Close; Difficult to Open or Close

  AS REPORTED, TWO PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR'S EXHIBITED STICKING ISSUES WITH THE GRASPER HANDLES WHEN THE USER ATTEMPTED TO GRASP THEM WITHIN AN UNSPECIFIED SCOPE. THE ISSUE WAS IDENTIFIED DURING THE UNSPECIFIED PROCEDURE. THE PHYSICIAN OPENED A NEW PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR DEVICE AND SUCCESSFULLY COMPLETED THE CASE. 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 22819374 ↗
• MalfunctionJun 17, 2025Difficult to Open or Close; Difficult 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 22232930 ↗
• MalfunctionMay 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 22036675 ↗
• MalfunctionMar 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE DISTRIBUTOR, THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR HAS SOME WHITE BUBBLES INSIDE THE PACKAGING. THE DEVICE WAS STORED IN DISTRIBUTOR´S WAREHOUSE, THE STORAGE CONDITIONS ARE REGULATED BY NOM-241-SSA1-2012, AT 52 HUMIDITY, 21CELSIUS DEGREES. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. THE CUSTOMER ATTACHED IMAGES OF WHAT APPEARS TO SHOW FOREIGN MATTER - WHITE BUBBLES, INSIDE THE PACKAGE. PATIENT WAS NOT INVOLVED. 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 21505252 ↗
• MalfunctionNov 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO ADDITIONAL PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314857 ↗
• MalfunctionNov 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 12DEC2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314707 ↗
• MalfunctionJan 18, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261720 ↗
• MalfunctionJan 18, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261719 ↗
• MalfunctionNov 13, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, PRIOR TO THE START OF A PERCUTANEOUS NEPHROLITHOTOMY. AS SOON AS THE PACKAGE OF A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR WAS OPENED, THE FACILITY COULD TELL THE BASKET WAS BROKEN. THE METAL PIECE OF THE BASKET WAS ALREADY BENT AND OUTSIDE OF THE HANDLE. A NEW SAME DEVICE WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065329 ↗
• MalfunctionOct 8, 2018Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943420 ↗
• MalfunctionOct 8, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

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

  Patient problems: No Patient Involvement

  MAUDE report 7942436 ↗
• MalfunctionSep 18, 2018Break; Break

  IT WAS REPORTED, AFTER OPENING THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR AND PRIOR TO PATIENT CONTACT, THEY FOUND THE NITINOL FIBER OF THE BASKET TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885446 ↗
• MalfunctionMar 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR WAS OPENED AND TESTED PRIOR TO USE WHEN THE BASKET WAS FOUND TO BE TWISTED. ANOTHER LIKE DEVICE WAS USED FOR THE SCHEDULED PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 7369324 ↗
• MalfunctionDec 20, 2017Break

  THE USER OPENED THE PACKAGE OF THE STONE EXTRACTOR, ACTUATED THE HANDLE AND FOUND A WIRE OF THE BASKET WAS BROKEN. ANOTHER STONE EXTRACTOR WAS USED INSTEAD FOR THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 7135023 ↗
• MalfunctionDec 20, 2017Material Separation

  IT WAS REPORTED THAT WHILE PERFORMING A FUNCTIONAL CHECK OF THE DEVICE PRIOR TO PATIENT CONTACT, THE PHYSICIAN NOTICED THAT THE BASKET WIRE LOOPS LOOKED SEPARATED, AND THE BASKET HAD A COLLAPSED OR CURLED SHAPE WHEN OPENED. VISUAL EXAMINATION NOTED THAT ONE OF THE FORMATION WIRES HAD BEEN CUT. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7134063 ↗
• MalfunctionDec 18, 2017Break; Material Discolored; Structural Problem

  IT WAS REPORTED THAT AFTER REMOVING SOME STONE FRAGMENTS, THE BASKET WAS NO LONGER OPENING OR CLOSING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE DEVICE WAS RETURNED AND EXAMINED, AND IT WAS FOUND TO HAVE A BROKEN BASKET WIRE AND SOME BLACK AND BLUE DISCOLORATION. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7124929 ↗
• MalfunctionApr 27, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERCUTANEOUS NEPHROLITHOTRIPSY PROCEDURE AND THE PERCNCIRCLE NITINOL TIPLESS STONE EXTRACTOR WIRE BROKE FROM THE HANDLE DURING THE PROCEDURE. THE OPERATOR REMOVED THE BROKEN DEVICE FROM THE PATIENT¿S BODY AND COMPLETED THE PROCEDURE BY USING A NEW PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR DEVICE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525283 ↗
• InjuryAug 22, 2016Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE THAT THE BASKET FAILED TO OPEN AND CLOSE CORRECTLY. THE STONE BECAME LODGED AND THE WIRE HANDLE HAD TO BE CUT APART.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5894251 ↗