Cook G06787Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002067875), received between Nov 10, 2016 and Sep 29, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Deformation Due to Compressive Stress

  It was reported that a Thal-Quick Chest Tube twisted and kinked.The chest tube was placed on (b)(6) 2026 in a 25-year-old male patient presenting to the emergency department with a spontaneous pneumothorax. The device was connected to a drainage system. Five days later, on (b)(6) 2026, despite functional drainage system suction, no bubbling in the drainage system was observed. The dressing was removed to check the drainage tube's path and assess for any kink. It was discovered that the tube was twisted on itself several times, which appeared to be preventing the suction from working correctly. Initially, the drain was untwisted, and an additional dressing was applied to the thigh to prevent recurrence. The following day, on (b)(6) 2026, as the absence of bubbling persisted, an attempt was made to clear the obstruction by injecting 10 mL of 0.9% NaCl. This maneuver temporarily improved the situation, resulting in the appearance of bubbles. However, given the lack of improvement on the X-ray, it was decided on (b)(6) 2026, to replace the chest tube with one of a different gauge. This incident resulted in a delay in the management and progression of the spontaneous pneumothorax, conse

  Patient problems: Pneumothorax

  MAUDE report 50935795 ↗
• MalfunctionJan 23, 2025Unraveled Material; Unraveled Material

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

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

  MAUDE report 21225565 ↗
• MalfunctionJan 19, 2024Break; Break

  IT WAS REPORTED THAT THE WIRE GUIDE OF A THAL-QUICK CHEST TUBE SET BROKE. DURING INSERTION OF THE DEVICE IN THE CHEST, THE WIRE GUIDE BECAME STUCK INSIDE THE INTRODUCER. BOTH COMPONENTS WERE REMOVED FROM THE PATIENT¿S BODY, AND IT WAS OBSERVED THAT THE WIRE BROKE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547574 ↗
• MalfunctionDec 19, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT THE GUIDE WIRE FROM A COOK THAL-QUICK CHEST TUBE SET FRAYED INTO FRAGMENTS. AFTER INSERTING THE GUIDEWIRE INTO THE PATIENT'S CHEST, IT WAS EXTRACTED. DURING THE EXTRACTION THE WIRE BECAME FRAYED INTO FRAGMENTS. 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 18355780 ↗
• MalfunctionJul 7, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED A PATIENT REQUIRED A THAL-QUICK CHEST TUBE SET FOR PLACEMENT OF A LEFT PLEURAL DRAIN. AFTER DRAIN PLACEMENT, THE WIRE GUIDE BECAME DIFFICULT TO REMOVE AND UNRAVELED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948653 ↗
• MalfunctionJan 7, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 9557886 ↗
• MalfunctionJun 5, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 8672065 ↗
• MalfunctionNov 10, 2016Unraveled Material; Unraveled Material

  PER THE MW (B)(4), REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS AND CUSTOMER RELATIONS, THE MANUFACTURER WAS INFORMED THAT THE NEONATAL NURSE PRACTITIONER WAS INSERTING A CHEST TUBE WHEN THE GUIDE WIRE BECAME FAULTY AND STARTED TO UNRAVEL IN THE MIDDLE OF THE WIRE PATIENT TOLERATED PROCEDURE WITH NO HARM AND NO ADVERSE EFFECTS. NO SECTION OF THE DEVICE OF THE DEVICE REMAINED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6092143 ↗