Cook G08454Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002084544), received between Jun 23, 2017 and Jun 23, 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.

• MalfunctionJun 23, 2017Unraveled Material; Unraveled Material

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A THAL-QUICK ABSCESS DRAINAGE CATHETER. THE CUSTOMER REPORTED THAT THE WIRE GUIDE FRAYED WHILE ATTEMPTING TO ADVANCE THE WIRE GUIDE INTO THE PATIENT. THE CLINICIAN WAS ABLE TO REMOVED THE WIRE GUIDE WITHOUT INJURY TO THE PATIENT. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665803 ↗