Cook G14429Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002144293), received between Feb 18, 2020 and Dec 13, 2024 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Device 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 20928989 ↗
• MalfunctionDec 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AN OPEN-END URETERAL CATHETER WAS RETURNED FOR INSPECTION. DURING THE INSPECTION, A RECTANGULAR INDENTATION APPROXIMATELY 2MM LONG WITH A SLIGHTLY MELTED APPEARANCE AT THE EDGES WAS FOUND. THERE WERE BLACK SPOTS ON THE INSIDE OF THE EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946722 ↗
• MalfunctionSep 29, 2022Break; Break

  AS REPORTED, UPON OPENING AN OPEN-END URETERAL CATHETER, THE TIP WAS BROKEN. THE DEVICE WAS REPLACED WITH A NEW DEVICE TO CONTINUE THE PROCEDURE WITHOUT ANY OTHER ISSUES. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 15506858 ↗
• InjuryApr 20, 2022Break; Break

  AS REPORTED, DURING A STENT PLACEMENT PROCEDURE, AN OPEN-END URETERAL CATHETER SEPARATED. TWO SMALL DEVICE FRAGMENTS REMAINED IN THE PATIENT BUT WERE SUCCESSFULLY RECOVERED BY THE SURGEON. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14160683 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9750051 ↗
• MalfunctionFeb 18, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721876 ↗