Cook G05464Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002054646), received between Jun 28, 2016 and Jun 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGING OF A THAL-QUICK CHEST TUBE TRAY CONTAINED FOREIGN MATTER. THE MEDICAL TEAM PREPPED FOR THE CHEST TUBE PLACEMENT PROCEDURE INSIDE THE PATIENT ROOM FOLLOWING STERILE PROCEDURES. WHEN THE CHEST TUBE TRAY WAS OPENED, A BLONDE HAIR-LIKE FIBER WAS NOTED TO BE SITTING ON THE CHEST TUBE ITSELF. THE TRAY WAS INTACT PRIOR TO OPENING IT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488566 ↗
• MalfunctionJan 15, 2026Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information

  MAUDE report 24080847 ↗
• MalfunctionApr 15, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A THAL-QUICK CHEST TUBE TRAY UNRAVELED DURING A PROCEDURE IN THE EMERGENCY ROOM (ER). AN "OBJECT" WAS NOTED ON CONFIRMATORY X-RAY AND A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS ORDERED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106664 ↗
• MalfunctionJun 28, 2016Material Separation; Material Separation

  THE SURGEON WAS TRYING TO ADVANCE THE CATHETER AND WHEN SHE PULLED IT OUT, THE END OF THE CATHETER WAS NEARLY BROKEN OFF. IF THE TIP COMPLETELY CAME OFF, IT WOULD HAVE BEEN FLOATING IN THE PLEURAL SPACE. 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 Consequences Or Impact To Patient

  MAUDE report 5755180 ↗