Cook G06786Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002067868), received between Apr 9, 2015 and Feb 18, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A THAL-QUICK CHEST TUBE SET WAS FOUND TO BE CONTAMINATED UPON OPENING THE PRODUCT, RESULTING IN THE PRODUCT NOT BEING USED FOR THE PLANNED PROCEDURE. THERE WAS NO PATIENT CONTACT. A PHOTO PROVIDED BY THE CUSTOMER SHOWS POSSIBLE PARTICULATE MATTER WITHIN THE SEALED PACKAGING. 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 24381064 ↗
• MalfunctionJun 17, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A THAL-QUICK CHEST TUBE WAS BEING INSERTED INTO THE PATIENT USING SELDINGER TECHNIQUE. THE GUIDE WIRE WAS INSERTED FIRST, FOLLOWED BY THE DILATOR. WHEN ADVANCING THE DRAINAGE CATHETER, THE ADVANCEMENT WAS NOT SMOOTH. UPON INSPECTION OF THE GUIDE WIRE, IT WAS DISCOVERED THAT IT WAS "BROKEN AND DAMAGED. THE WIRE WAS REMOVED FROM THE PATIENT WITHOUT ANY HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733912 ↗
• MalfunctionJun 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED FOUR THAL-QUICK CHEST TUBE SETS WERE USED ON ONE PATIENT DURING A THORACENTESIS. THIS REPORT IDENTIFIES THE SECOND DEVICE USED. THE FIRST DEVICE (MEDWATCH 1820334-2018-01654) WAS INSERTED AND THE DOCTOR OBSERVED COILING OF THE WIRE AND CATHETER. THE DEVICE WAS REMOVED AND FOUND TO BE FRAYED/DAMAGED. A SECOND DEVICE (MEDWATCH 1820334-2018-01721) FROM THE SAME LOT WAS INSERTED AND DRAINAGE BEGAN. THE DOCTOR OBSERVED AN INTRA-PLEURAL LOOP/KINK AND AT A CERTAIN POINT THE DRAINAGE STOPPED. LIQUID WAS STILL PRESENT INSIDE THE CAVITY, THEREFORE, THE DEVICE WAS REMOVED. A DIFFERENT DOCTOR OPENED A THIRD DEVICE FOR INSERTION AND WHEN TRYING TO REMOVE THE WIRE GUIDE, ENCOUNTERED RESISTANCE. THE DEVICE WAS VERY DIFFICULT TO REMOVE AND BOTH THE WIRE GUIDE AND CATHETER WERE REMOVED. THE SAME DOCTOR USED A FOURTH AND FINAL DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THREE OF THE FOUR REPORTED DEVICES WERE DISCARDED. ONE DEVICE, IT IS UNKNOWN WHICH FAILURE IT WILL PRESENT, WILL BE RETURNED FOR INVESTIGATION. TO DATE, ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE AD

  Patient problems: No Code Available

  MAUDE report 7581800 ↗
• MalfunctionJun 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED FOUR THAL-QUICK CHEST TUBE SETS WERE USED ON ONE PATIENT DURING A THORACENTESIS. THIS REPORT IDENTIFIES THE FIRST DEVICE USED. THE FIRST DEVICE (MEDWATCH 1820334-2018-01654) WAS INSERTED AND THE DOCTOR OBSERVED COILING OF THE WIRE AND CATHETER. THE DEVICE WAS REMOVED AND FOUND TO BE FRAYED/DAMAGED. A SECOND DEVICE (MEDWATCH 1820334-2018-01721) FROM THE SAME LOT WAS INSERTED AND DRAINAGE BEGAN. THE DOCTOR OBSERVED AN INTRA-PLEURAL LOOP/KINK AND AT A CERTAIN POINT THE DRAINAGE STOPPED. LIQUID WAS STILL PRESENT INSIDE THE CAVITY, THEREFORE, THE DEVICE WAS REMOVED. A DIFFERENT DOCTOR OPENED A THIRD DEVICE FOR INSERTION AND WHEN TRYING TO REMOVE THE WIRE GUIDE, ENCOUNTERED RESISTANCE. THE DEVICE WAS VERY DIFFICULT TO REMOVE AND BOTH THE WIRE GUIDE AND CATHETER WERE REMOVED. THE SAME DOCTOR USED A FOURTH AND FINAL DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THREE OF THE FOUR REPORTED DEVICES WERE DISCARDED. ONE DEVICE, IT IS UNKNOWN WHICH FAILURE IT WILL PRESENT, WILL BE RETURNED FOR INVESTIGATION. TO DATE, ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADD

  Patient problems: No Code Available

  MAUDE report 7581637 ↗
• InjuryNov 17, 2016Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER THE MW(B)(4), REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT THE GUIDE WIRE WAS NOT REMOVED AFTER CHEST TUBE PLACEMENT. THE REPORTER ALLEGED THAT THE "TAG THAT SAYS "REMOVE DILATOR AFTER CHEST TUBE INSERTION" IS NOT VERY NOTICEABLE OR UNDERSTANDABLE." IT WAS FURTHER REPORTED TO THE MANUFACTURER IN RESPONSE TO INQUIRY'S THAT: THE DRAINAGE BEING PERFORMED WAS PNEUMOTHORAX, NO UNINTENDED SECTIONS OF THE DEVICE REMAINED IN THE PATIENT, AN ADDITIONAL PROCEDURE WAS PERFORMED, THE COMPLAINED DEVICE WAS IN PLACE FOR 1 DAY, THE CHEST TUBE WAS REPLACED WITH A DIFFERENT DEVICE AND REMAINED IN FOR 2 DAYS, THE PATIENT IS DOING WELL AND NO ADVERSE EVENTS OCCURRED DUE TO THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6110276 ↗
• MalfunctionApr 9, 2015Material Separation

  THE HUB SEPARATED FROM THE CATHETER SHAFT ONE WEEK AFTER INSERTION. THE DEVICE WAS REMOVED AS PREVIOUSLY INTENDED AND NO OTHER CATHETER WAS INSERTED. PHOTO IMAGES WERE PROVIDED BUT VERY LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND THE DEVICE WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4687617 ↗