Cook G05453Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002054530), received between Aug 14, 2017 and Sep 7, 2017 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2017Break; Break

  AN INTERNATIONAL CUSTOMER REPORTED THAT PRIOR TO PERFORMING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN REALIZED THAT ONE OF THE THAL-QUICK CHEST TUBE SET DILATORS WAS BROKEN ON ITS DISTAL END. THE PHYSICIAN TOOK ANOTHER DRAINAGE AND PLACED IT WITHOUT ANY PROBLEMS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848336 ↗
• MalfunctionAug 14, 2017Difficult to Remove; Physical Property Issue

  IT WAS REPORTED THAT AFTER PLACING THE DRAINAGE CATHETER (LEFT PLEURA), THE PHYSICIAN TRIED TO REMOVE THE WIRE GUIDE. HOWEVER, DIFFICULTY WAS ENCOUNTERED. THE PHYSICIAN EXERTED MORE FORCE ON THE WIRE GUIDE UNTIL IT BEGAN COMING OUT OF THE PATIENT¿S CHEST. IT WAS NOTED THE WIRE GUIDE EXHIBITED COIL ELONGATION. A SECOND DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN NOTED THAT THE ACCOMPANYING WIRE GUIDE OF THE SECOND DRAINAGE CATHETER (UNKNOWN LOT) ALSO EXHIBITED COIL ELONGATION IN THE SAME LOCATION AFTER THE PHYSICIAN EXAMINED IT AND EXERTED FORCE ON IT FOLLOWING THE PLACEMENT OF THE SECOND DRAINAGE CATHETER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT SUFFERED ADDITIONAL PAIN CAUSED BY THE NEW DRAINAGE CATHETER WHICH WAS PLACED.

  Patient problems: Pain

  MAUDE report 6792309 ↗
• MalfunctionAug 14, 2017Burst Container or Vessel; Split

  IT WAS REPORTED THAT PRIOR TO THE UNKNOWN PROCEDURE, IT WAS NOTED THERE WAS A BURST IN THE 14F DILATOR. DEVICE IMAGING IDENTIFIED THE DILATOR TIP WAS SPLIT.

  Patient problems: No Information

  MAUDE report 6791933 ↗