Cook G02961Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002029613), received between Jan 12, 2017 and Jan 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2017Unraveled Material; Unraveled Material

  AS REPORTED TO CUSTOMER RELATIONS: AT THE INSERTION OF THE CATHETER THROUGH THE JUGULAR VEIN, THE GUIDE BECAME UNDONE WHEN PULLED, RESEMBLING A SPRING. ANOTHER CATHETER FROM COOK WAS USED AND THE PROCEDURE ENDED WITHOUT INTERCURRENCES. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6245600 ↗