NCompass G36251Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002362512), received between May 7, 2018 and Apr 20, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1787-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break; Difficult to Open or Close

  IT WAS REPORTED THAT THE HANDLE OF A N-COMPASS NITINOL STONE EXTRACTOR BROKE. THE SURGEON PERFORMED A DUCTOTOMY OF THE CYSTIC DUCT AND SUCCESSFULLY COMPLETED A CHOLANGIOGRAM USING A 5 FR CHOLANGIO CATHETER. MULTIPLE STONES WERE IDENTIFIED AND CLEARED FROM THE CYSTIC DUCT; HOWEVER, THE CHOLANGIOGRAM REVEALED AN ADDITIONAL STONE IN THE COMMON BILE DUCT. THE SURGEON ELECTED TO PROCEED WITH A COMMON DUCT EXPLORATION TO REMOVE THE STONE. A WIRE GUIDE WAS ADVANCED THROUGH THE CHOLANGIO CATHETER, AFTER WHICH THE CHOLANGIO CATHETER WAS REMOVED. A 6 MM BILIARY BALLOON CATHETER WAS THEN ADVANCED INTO THE DUCTOTOMY OVER THE WIRE GUIDE. DILATION WAS PERFORMED USING A SPHERE INFLATION DEVICE WITH A 50% CONTRAST MEDIUM AND 50% SALINE SOLUTION. A SUCCESSFUL DILATION WAS ACHIEVED FOLLOWING THE PRESCRIBED 5-MINUTE DILATION PERIOD. THE BALLOON CATHETER WAS REMOVED, LEAVING THE WIRE GUIDE IN PLACE, AND A CHOLANGIOSCOPE WAS ADVANCED OVER THE WIRE GUIDE. THE WIRE GUIDE WAS THEN REMOVED, AND THE N-COMPASS BASKET WAS ADVANCED INTO THE CYSTIC DUCT. THE STONE WAS VISUALIZED; HOWEVER, THE RESOLUTION OF THE SCOPE IMAGE WAS NOTED TO BE SUBPAR, RESULTING IN A SOMEWHAT BLURRY VIEW. THE STONE WAS LOCATED APPROXI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931719 ↗
• MalfunctionAug 21, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, UPON OPENING THE PACKAGE OF A N-COMPASS NITINOL STONE EXTRACTOR, THE BASKET FAILED TO RELEASE. ANOTHER DEVICE WAS OBTAINED 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 22860587 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT UPON OPENING TWO N-COMPASS NITINOL STONE EXTRACTORS IT WAS DISCOVERED THE BASKETS HAD A BROKEN WIRE. THE DEVICES DID NOT MAKE PATIENT CONTACT. A NEW LIKE 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 22371721 ↗
• MalfunctionSep 3, 2019Difficult 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 Known Impact Or Consequence To Patient

  MAUDE report 8958057 ↗
• MalfunctionSep 3, 2019Difficult 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 Known Impact Or Consequence To Patient

  MAUDE report 8957954 ↗
• MalfunctionApr 24, 2019Difficult to Open or Close; Difficult to Open or Close

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546145 ↗
• MalfunctionDec 16, 2018Break; Difficult to Open or Close

  IT WAS REPORTED THAT THE N-COMPASS NITINOL BASKET WOULD NOT OPEN OR CLOSE. A NEW BASKET WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE BASKET SHEATH HAD THE APPEARANCE OF BEING ACCORDION 2 MM FROM THE SUPPORT SHEATH AND IT WAS ALSO NOTED THE BASKET FORMATION HAD A BROKEN WIRE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8167883 ↗
• MalfunctionMay 7, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED A ¿GIVE¿ WAS FELT WHEN MANIPULATING THE N-COMPASS NITINOL STONE EXTRACTOR AND CONCERN OF DEVICE FRAGMENTS BEING LEFT WITHIN THE PATIENT WAS EXPRESSED. A COOK SALES REPRESENTATIVE VISITED THE USER FACILITY AND CONFIRMED ALL DEVICE COMPONENTS WERE INTACT. THE DEVICE DOES NOT FUNCTION AS INTENDED, HOWEVER, IT DID NOT PHYSICALLY BREAK. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS NOT BEEN PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489803 ↗