Cook G36250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002362505), received between Jun 26, 2017 and Mar 12, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Material Separation

  IT WAS REPORTED THAT AN N-COMPASS NITINOL STONE EXTRACTOR BASKET WAS BROKEN. THE SURGEON WAS UNAWARE THAT THE BASKET HAD BROKEN AND WAS UNSURE WHEN THE BREAKAGE OCCURRED. AN X-RAY WAS PERFORMED ON THE PATIENT TO CONFIRM THAT NO PIECES OF THE BASKET REMAINED IN SITU. NO PORTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. 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 24579853 ↗
• MalfunctionOct 27, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, UPON OPENING THE PACKAGE PRIOR TO THE PROCEDURE, IT WAS FOUND THAT THE N-COMPASS NITINOL STONE EXTRACTOR COULD NOT BE OPENED. A NEW LIKE-DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 23393536 ↗
• MalfunctionOct 27, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, UPON OPENING THE PACKAGE PRIOR TO THE PROCEDURE, IT WAS FOUND THAT THE N-COMPASS NITINOL STONE EXTRACTOR WAS UNABLE TO BE OPENED OR CLOSED. A NEW LIKE-DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A CUSTOMER PROVIDED PHOTOGRAPH SHOWS THE HANDLE HAS BEEN DISASSEMBLED. IT IS POSSIBLE THAT WHEN ATTEMPTING TO DISCONNECT THE HANDLE FROM THE HOOP, THE USER UNSCREWED THE HANDLE FROM THE MLLA (MALE LUER LOCK ADAPTER) INSTEAD OF UNSCREWING THE MLLA FROM THE RED HOOP CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393463 ↗
• MalfunctionOct 27, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A N-COMPASS NITINOL STONE EXTRACTOR WAS UNABLE TO BE OPENED OR CLOSED PRIOR TO AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. UPON OPENING THE PACKAGE, IT WAS FOUND THAT THE PLASTIC TUBE HAD DETACHED, CAUSING THE INABILITY OF THE BASKET TO OPEN OR CLOSE. A NEW LIKE-DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. A CUSTOMER PROVIDED PHOTOGRAPH SHOWS THE HANDLE HAS BEEN DISASSEMBLED. IT APPEARED LIKELY THE USER UNSCREWED THE HANDLE FROM THE MLLA ON THE DISTAL END OF THE HANDLE, INSTEAD OF UNSCREWING THE MLLA FROM THE RED CONNECTOR ON THE HOOP. 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 23393320 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF A N-COMPASS NITINOL STONE EXTRACTOR, THE "HOLDER OF THE SHEATH" WAS DISCOVERED TO BE BROKEN. THE DEVICE WAS NOT USED, AND 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 22860500 ↗
• 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 22860451 ↗
• MalfunctionJul 1, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT UPON OPENING A N-COMPASS NITINOL STONE EXTRACTOR IT WAS DISCOVERED THE HANDLE WAS INOPERABLE. THE DEVICE 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 22371873 ↗
• MalfunctionJul 1, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT UPON OPENING A N-COMPASS NITINOL STONE EXTRACTOR IT WAS DISCOVERED THE BASKET DID NOT OPEN. THE DEVICE 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 22370476 ↗
• MalfunctionDec 16, 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 Patient Involvement

  MAUDE report 9475503 ↗
• MalfunctionJun 26, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED TO UNDERGO A CHOLEDOCHOTOMY USING A N-COMPASS NITINOL STONE EXTRACTOR. THE USER FOUND THAT THE OUTER SHEATH OF THE DEVICE NEARBY THE HANDLE END WAS BROKEN. THE EVENT WAS NOTED PRIOR TO USE DURING PROCEDURAL PREPARATION. PHOTOS SUPPLIED BY THE CUSTOMER SHOW A SEVERING OF THE CATHETER SHEATH JUST DISTAL TO THE FLARE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666939 ↗