Cook G06339Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002063396), received between Mar 28, 2018 and Jan 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON THE NURSE OPENING THE PACKAGE OF A COOK THAL-QUICK ABSCESS DRAINAGE SET, IT WAS DISCOVERED THAT THE DEVICE "FELL APART." NO PATIENT CONTACT WAS MADE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING HOW THE DEVICE "FELL APART," BUT HAS NOT BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254708 ↗
• MalfunctionMar 28, 2018Break; Entrapment of Device; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT THE DILATOR OF THE THAL-QUICK ABSCESS DRAINAGE SET BECAME STUCK IN THE DRAINAGE CATHETER. THIS DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SET. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES. THE DEVICE WAS RETURNED AND EXAMINED, REVEALING THAT IT WAS ACTUALLY THE DILATOR WITH THE GUIDEWIRE LODGED INSIDE OF IT, ALONG WITH AN UNIDENTIFIED HARDENED FOREIGN MATTER. IT WAS ALSO FOUND THAT THE SAFETY WIRE WAS BROKEN, AND THE COILS WERE ELONGATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377082 ↗