Cook G05463Recalls & reported problems
Cook Incorporated · Thal-Quick Chest Tube Tray · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002054639), received between Aug 10, 2017 and Jan 20, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Failure to Advance1
- Physical Resistance/Sticking1
Patient problems
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pneumothorax1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS EVENT NO LONGER MEETS THE DEFINITION OF A REPORTABLE COMPLAINT. SEE H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193250 ↗MalfunctionJan 25, 2021Physical Resistance/Sticking
ICU PATIENT'S OXYGEN SATURATION DROPPED. PATIENT HAD A PNEUMOTHORAX AND NEEDED CHEST TUBE. THE MD EMERGENTLY ATTEMPTED TO PLACE CHEST TUBE. WHEN USING THE THAL QUICK CHEST TUBE TRAY, THE OBTURATOR AND NEEDLE STUCK TOGETHER. THE HEALTH CARE PROVIDERS NEEDED TO OPEN ANOTHER KIT TO COMPLETE THE CHEST TUBE PLACEMENT.
Patient problems: Low Oxygen Saturation; Pneumothorax
MAUDE report 11222258 ↗InjuryAug 10, 2017Failure to Advance
WHILE INSERTING THE CHEST TUBE IN A PERPENDICULAR DIRECTION INTO THE 4TH INTERCOSTAL RIB SPACE GLANCING SLIGHTLY OFF THE SUPERIOR BORDER OF THE RIB. THE WIRE PASSED THROUGH THE NEEDLE WITH SLIGHT AMOUNT OF FRICTION. THE USER ATTEMPTED TO PULL THE NEEDLE BACK OVER THE WIRE. HOWEVER THE NEEDLE DID NOT PASS. THE USER WITHDREW THE ENTIRE DEVICE ENACT (WIRE + NEEDLE) FROM THE PATIENT. THE USER THEN HAD TO CHOOSE AN ALTERNATE ENTRY POINT "DOUBLE-STICK". THE NEW CHEST TUBE WENT IN WITHOUT FURTHER COMPLICATION.
Patient problems: No Code Available
MAUDE report 6784996 ↗
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- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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