Cook G06345Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002063457), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 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.

• InjuryJul 8, 2022Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  IT WAS REPORTED THAT A THAL-QUICK ABSCESS DRAINAGE SET DID NOT DRAIN WELL. THE DEVICE WAS REQUIRED FOR A STUDY PROCEDURE (MDR-1919) AND WAS PLACED ON (B)(6) 2021 FOR AN ABSCESS LOCATED IN THE LEFT RETROPERITONEUM. DILATION WAS PERFORMED PRIOR TO CATHETER PLACEMENT AND COMPUTED TOMOGRAPHY (CT) VISUAL GUIDANCE WAS UTILIZED DURING THE PROCEDURE. THE DEVICE WAS PLACED SUCCESSFULLY AND DRAINAGE WAS ESTABLISHED. ON (B)(6) 2022 THE CATHETER WAS REMOVED AND REPLACED WITH A LARGER CATHETER DUE TO THE THICKNESS OF THE FLUID. NO ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT'S EXIT FROM THE STUDY.

  Patient problems: Failure of Implant

  MAUDE report 14959651 ↗