NCompass G32702Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002327023), received between Sep 27, 2017 and Aug 4, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132575 ↗
• MalfunctionApr 1, 2026Break; Fracture

  AS REPORTED, DURING URETEROSCOPIC STONE REMOVAL PROCEDURE, THE TIP OF THE 'NCOMPASS NITINOL STONE EXTRACTOR' FELL OFF. THE NCOMPASS WAS OPENED AND TESTED PRIOR TO USE WITH NO ISSUES. IT WAS USED TO REMOVE THREE STONE FRAGMENTS. WHEN THE USER ATTEMPTED TO REMOVE THE FOURTH FRAGMENT, THE TIP FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY RETRIEVING THE FRAGMENT AND USING ANOTHER NCOMPASS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754946 ↗
• MalfunctionFeb 6, 2026Loss of or Failure to Bond; Difficult to Open or Close

  IT WAS REPORTED, TWO NCOMPASS NITINOL STONE EXTRACTORS WOULD NOT OPEN AND CLOSE DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THIS REPORT WILL BE FOR DEVICE # 2. REFERENCE PATIENT IDENTIFIER (B)(6) FOR DEVICE # 1. A THIRD SAME TYPE DEVICE 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 24277902 ↗
• MalfunctionFeb 6, 2026Break; Difficult to Open or Close

  IT WAS REPORTED, TWO NCOMPASS NITINOL STONE EXTRACTORS WOULD NOT OPEN AND CLOSE DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THIS REPORT WILL BE FOR DEVICE # 1. REFERENCE PATIENT IDENTIFIER (B)(6) FOR DEVICE # 2. A THIRD SAME TYPE DEVICE 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 24277834 ↗
• MalfunctionSep 9, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED, THE NCOMPASS NITINOL STONE EXTRACTOR WAS STUCK IN THE OPEN POSITION AND WOULD NOT CLOSE, PRIOR TO AN UNSPECIFIED PROCEDURE. THE DEVICE WAS INSPECTED AND THERE WERE NO OBVIOUS DEFECTS. THE ISSUE WAS FOUND WHILE TESTING THE FUNCTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME LIKE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23003712 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  NO NEW INFORMATION HAS BEEN PROVIDED DUE TO PRIVACY RESTRICTIONS OF THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173188 ↗
• MalfunctionJan 8, 2018Kinked; Difficult to Open or Close; Kinked; Difficult to Open or Close

  IT WAS REPORTED THE NCOMPASS NITINOL STONE EXTRACTOR WIRE KINKED APPROXIMATELY 3CM FROM THE BASKET HANDLE, PREVENTING OPERATION OF THE BASKET. 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 7171670 ↗
• MalfunctionDec 19, 2017Break; Detachment Of Device Component

  THE COMPLAINANT REPORTED THAT THE BASKET WAS OPENED AND CLOSED BEFORE USING DOWN THE URETEROSCOPE; THE BASKET SUBSEQUENTLY "BROKE OFF." THE BASKET COULD NOT BE USED AND ANOTHER BASKET WAS USED FOR CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128495 ↗
• MalfunctionSep 27, 2017Device Damaged Prior to Use; Component Missing; Device Damaged Prior to Use; Component Missing

  DR.(B)(6) AND HIS ASSISTANT DISCOVERED BEFORE THE OPERATION THAT SHEATH NEAR THE HANDLE WAS TAKEN OFF FROM THE NCOMPASS NITINOL STONE EXTRACTOR AND IT WAS SQUASHED. THE DEVICE WAS NOT USED. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES OR EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6896695 ↗