Cook G05161Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002051614), received between Jun 30, 2016 and Mar 30, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE GUIDEWIRE INCLUDED IN A THAL-QUICK CHEST TUBE SET SEPARATED. A THAL-QUICK CHEST DRAIN WAS BEING PLACED IN AN UNKNOWN PATIENT WITH PLEURAL FLUID. THE PROCEDURE PROGRESSED WITHOUT ISSUE UNTIL THE STAGE WHERE THE GUIDEWIRE WAS TO BE WITHDRAWN THROUGH THE DRAIN. AT THIS POINT, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO REMOVE THE WIRE. IN RESPONSE, THE ENTIRE DRAIN WAS WITHDRAWN FROM THE PATIENT. UPON INSPECTION BY THE USER, IT WAS NOTED THAT THE GUIDEWIRE HAD PARTIALLY FRACTURED, WITH A SEGMENT OF THE WIRE REMAINING INSIDE THE THORACIC CAVITY. THE RETAINED WIRE FRAGMENT WAS SUBSEQUENTLY RETRIEVED IN FULL. EXAMINATION OF THE WIRE REVEALED THAT ONE STRAND OF THE STEEL WIRE HAD BROKEN, AND THE REMAINING WIRES EXHIBITED SIGNS OF TWISTING. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED 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 24717830 ↗
• MalfunctionJul 25, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A GUIDEWIRE FROM A THAL-QUICK CHEST TUBE SET UNRAVELED DURING USE. RESISTANCE OR A "SNAGGING SENSATION" WAS MET UPON INSERTION OF THE GUIDEWIRE INTO THE NEEDLE. WHEN THE GUIDEWIRE WAS REMOVED, IT WAS NOTED TO BE "FRAYED". NO "BACK AND FORTH MOVEMENT" OF THE GUIDEWIRE WITHIN THE NEEDLE WAS REPORTED. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. 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 22612983 ↗
• InjuryOct 16, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

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

  Patient problems: Discomfort; Pain

  MAUDE report 20464560 ↗
• MalfunctionJun 26, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203552 ↗
• MalfunctionApr 19, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE THAL-QUICK CHEST TUBE SET UNRAVELED DURING A CHEST TUBE PLACEMENT PROCEDURE ON AN UNKNOWN PEDIATRIC PATIENT. FOLLOWING PLACEMENT OF THE DEVICE, THE WIRE WAS REMOVED FROM THE CATHETER AND THE TIP WAS FOUND TO BE KINKED, WITH THE WIRE BEING DESCRIBED AS "THIN AND CURVY." THE UNRAVELED WIRE GUIDE WAS ABLE TO BE COMPLETELY REMOVED FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769505 ↗
• MalfunctionFeb 28, 2023Material Twisted/Bent; Material Twisted/Bent

  A PATIENT OF UNKNOWN GENDER AND AGE UNDERWENT A PROCEDURE TO PLACE A COOK THAL-QUICK CHEST TUBE ON (B)(6) B202. THE DEVICE WAS PLACED IN THE "AXILLARY" FOR A SPONTANEOUS PNEUMOTHORAX. AFTER THE DEVICE WAS PLACED, TWO X-RAYS WERE PERFORMED ON (B)(6) 2023 AND (B)(6) 2023. IT WAS NOT POSSIBLE TO SEE THE RADIOPAQUE MARKING ON THE CHEST TUBE (INDICATED IN THE INSTRUCTIONS FOR USE) WHICH WOULD HAVE ASSISTED IN CONFIRMING THE CORRECT POSITIONING OF THE CATHETER. INABILITY TO CONFIRM CORRECT PLACEMENT REQUIRED INCREASED MONITORING OF THE DRAIN AND THE PATIENT UNTIL THE DRAIN WAS REMOVED. THE DEVICE WAS REMOVED ON AN UNKNOWN DATE AND RETURNED TO THE MANUFACTURER FOR INVESTIGATION ON (B)(6) 2023. THE PRELIMINARY DEVICE FAILURE ANALYSIS INDICATED THE CATHETER HAD A RADIOPAQUE LINE EXTENDING THE LENGTH OF THE CATHETER. HOWEVER, THE CATHETER WAS NOTED TO BE KINKED IN TWO AREAS. THE FOCUS OF THIS REPORT IS THE KINKED COOK THAL-QUICK CHEST TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454648 ↗
• MalfunctionJul 28, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE INCLUDED IN THE THAL-QUICK CHEST TUBE SET HAD UNRAVELED UPON REMOVAL DURING A CHEST TUBE INSERTION. INITIAL PLACEMENT OF THE WIRE WAS QUICK AND EASY. THE DILATOR AND THE THAL-QUICK CHEST TUBE ADVANCED EASILY. THE USER REPORTED ROTATING "A HALF TURN OR SO," WHEN ADVANCING THE DILATOR. NO KINKING OF THE WIRE WAS OBSERVED UPON ADVANCEMENT INTO THE TUBES. DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO REMOVE THE WIRE GUIDE FROM THE TUBE, AS THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT THE DILATOR FROM THE GUIDEWIRE. WHEN THE WIRE WAS FINALLY PULLED OUT OF THE CHEST TUBE, IT WAS REPORTED THAT "THE WIRE WAS NOTICEABLY BROKEN AND HAD FOLDED BACK UPON ITSELF AND JAMMED IN THE DILATOR." A 1CM SECTION OF THE WIRE WAS DISCOVERED TO BE UNRAVELED/STRETCHED. THE PATIENT REQUIRED TO HAVE THE PROCEDURE RESTARTED, RESULTING IN ADDITIONAL INVASIVE CHEST WALL ACCESS. NO OTHER HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121882 ↗
• MalfunctionJan 2, 2020Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE OF A THAL-QUICK CHEST TUBE SET "TORE WHEN PULLED BACK" DURING AN EMERGENCY CHEST TUBE PLACEMENT PROCEDURE. PHOTOS OF THE DEVICE SHOWED THE WIRE TO BE ELONGATED. DURING USE, THE WIRE WAS REPORTED TO BE "NOT POSSIBLE TO PULL OUT" AND "STRETCHED" WITH A "WEAK SPOT ON TIP". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537774 ↗
• InjuryOct 16, 2019Material Separation; Material Separation

  ON 12NOV2019, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DEVICE WAS CONNECTED TO ANOTHER MANUFACTURER'S DRY SUCTION WATER SEAL CHEST DRAIN AT THE TIME OF THE INCIDENT.

  Patient problems: Confusion/ Disorientation; No Code Available

  MAUDE report 9198610 ↗
• MalfunctionAug 1, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851695 ↗
• MalfunctionAug 16, 2017Kinked; Material Separation; Failure to Advance

  IT WAS REPORTED DURING THE PATIENT'S CHEST TUBE (CT) INSERTION OF THE CHEST DRAINAGE CATHETER, THE WIRE COULD NOT BE ADVANCED AS THE END OF THE WIRE STARTED BENDING AND CURLING BACK. AS A RESULT, THE WIRE WAS REMOVED AND A NEW WIRE WAS USED. IT WAS NOTED THE WIRE GUIDE RELATED TO THE EVENT WAS KINKED. DEVICE IMAGING IDENTIFIED A KINK IN THE WIRE GUIDE THAT ALSO DISPLAYED COIL SEPARATION.

  Patient problems: No Code Available

  MAUDE report 6796826 ↗
• MalfunctionAug 15, 2017Device Markings/Labelling Problem

  THE MARKINGS ON THE CHEST TUBE DOES NOT ACCOUNT FOR THE 3 MILLIMETER PART OF THE CATHETER WHERE THE HOLES ARE. THE USER STATES THIS CREATES THE POTENTIAL FOR THE CATHETER BEING PLACED TOO FAR. THE USER FACILITY NOTED INCIDENTS WHERE THE DRAINS HAVE BEEN PLACED TOO FAR. IN ONE CASE IT WAS PLACED TO FAR IN A PRETERM INFANT WHERE DIAPHRAGMATIC PARALYSIS DUE TO PHRENIC NERVE PALSY (CAPTURED ON REPORT NUMBER 1820334-2016-00437).

  Patient problems: Nervous System Injury

  MAUDE report 6795516 ↗
• MalfunctionAug 14, 2017Bent; Kinked; Material Twisted/Bent

  IT WAS REPORTED DURING THE PATIENT'S PNEUMOTHORAX DRAINAGE PROCEDURE, IT WAS NOTED THE GUIDE WIRE BECAME TWISTED AND BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. VISUAL INSPECTION OF THE DEVICE ALONG WITH DEVICE IMAGING IDENTIFIED THE STIFFENER WAS SIGNIFICANTLY KINKED AND TWISTED NEAR THE POINT OF SEPARATION.

  Patient problems: No Information

  MAUDE report 6791749 ↗
• InjuryJun 30, 2016Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PER CUSTOMER: " PLEASE NOTE THAT WHILE DOING THE CHEST DRAIN INSERTION, THE MARKING ON THE THAL-QUICK CHEST DRAIN SET BY COOK MEDICAL CAN BE POTENTIALLY CONFUSING. THE MARKED MEASUREMENT OF 5 CM STARTS FROM WHERE THE HOLES END ON THE CHEST DRAIN CATHETER. THIS MEASUREMENT DOES NOT TAKE INTO ACCOUNT THE FIRST 3 CM OF THE CATHETER WITH THE HOLES. AND SO THERE IS A POTENTIAL OF PUSHING THE CHEST DRAIN TOO FAR IF ONE IS NOT CAREFUL. FOR ALL PRACTICAL PURPOSES FOR THE BABIES WE LOOK AFTER, ONCE ALL THE HOLES ARE INSIDE THE CHEST WALL, ONE DOES NOT NEED TO PUSH THE CATHETER ANY FURTHER. PLEASE ASK ONE OF THE CONSULTANTS, IF IT'S NOT CLEAR STILL." PER CUSTOMER LETTER ATTACHED: "WE HAVE HAD A NUMBER OF INCIDENTS RECENTLY WHERE CHEST DRAINS HAVE BEEN IN TOO FAR IN SMALL PRE-TERM INFANTS AND ONE CASE OF A DIAPHRAGMATIC PARALYSIS DUE TO PHRENIC NERVE PALSY WHICH MAY BE RELATED TO THIS. THERE IS A MEASUREMENT OF "5CM" MARKED ON THE DRAIN BUT ACTUALLY THIS IS FORM WHERE THE HOLES END ON THE CHEST DRAIN CATHETER. THIS IS CONFUSING AS ONE WOULD ASSUME THAT THIS IS FROM THE TIP OF THE CATHETER. IN FACT IF ONE MEASURES FROM THE TIP OF THE CATHETER THE MARKING OF "5CM" IS ACTUALLY 8CM FROM THE TIP W

  Patient problems: Paralysis

  MAUDE report 5761458 ↗