Perc NCircle G27234Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002272347), received between Aug 16, 2017 and Feb 20, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR¿S PACKAGE CONTAINED FOREIGN MATTER ¿DEBRIS." THE ISSUE WAS FOUND PRIOR TO OPENING THE PACKAGE ON DELIVERY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. REPORTEDLY, THE DEVICES ARE KEPT IN AN OUTWARDS AREA WHICH IS AN AIR CONDITIONED AND CONTROLLED ENVIRONMENT. A PHOTO PROVIDED SHOWED BROWN RUST-LIKE MATERIAL IN THE PACKAGE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421761 ↗
• MalfunctionMar 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, A DARK STAIN IN THE ROD NEAR THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR'S HANDLE WAS IDENTIFIED DURING THE PROCESS OF RECEIVING AND CHECKING PRODUCTS AT THE DISTRIBUTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008149 ↗
• MalfunctionNov 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  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 18069715 ↗
• MalfunctionMar 25, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THE PACKAGING OF A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR WAS PERFORATED. THIS WAS NOTED UPON RECEIVING THE DEVICE AND PRIOR TO PATIENT USE OR CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904706 ↗
• MalfunctionAug 11, 2021Break; 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 12308944 ↗
• 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 7943364 ↗
• MalfunctionFeb 22, 2018Device Operational Issue; Difficult to Open or Close; Device Operational Issue; Difficult to Open or Close

  IT WAS REPORTED THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR BASKET APPEARS TO NOT OPEN OR EVEN EXTEND PROPERLY FROM THE DISTAL END. THERE WERE NO ADVERSE CONSEQUENCES OR EFFECTS TO THE PATIENT REPORTED. NO FURTHER INFORMATION HAS BEEN FORTHCOMING DESPITE MULTIPLE ATTEMPTS TO OBTAIN PATIENT, DEVICE AND EVENT DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288700 ↗
• MalfunctionDec 20, 2017Break

  IT WAS REPORTED THAT DURING A STONE EXTRACTION PROCEDURE THE BASKET SNAPPED. THE STONE WAS REPORTED TO BE VERY HARD AND THE SURGEON TRIED TO PULL THE STONE THROUGH THE SHEATH WHEN THE BASKET WIRES WERE CUT IN TWO SEPARATE PLACES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES 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 7134472 ↗
• MalfunctionDec 14, 2017Difficult to Open or Close

  DURING THE PROCEDURE, THE BASKETS DID NOT OPEN WHEN PUSHING THE HANDLES. IN ADDITION, A VISUAL EXAMINATION NOTED THAT THE BASKET FORMATION HAS TWO WIRES CUT AND PART OF THE BASKET FORMATION WIRES APPEAR TO BE MISSING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117974 ↗
• MalfunctionAug 16, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  UPON OPENING THE PACKAGE CONTAINING THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR, THE TIP WAS NOTED TO BE DIRTY AND BROKEN. THE DEVICE WAS NOT USED; IT DID NOT MAKE CONTACT WITH A PATIENT. THERE WAS NO PATIENT IMPACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS RESULTING FROM THIS ISSUE.

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

  MAUDE report 6798417 ↗