Cook G06336Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002063365), received between Jul 8, 2022 and Jul 8, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2022Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  IT WAS REPORTED THAT A THAL-QUICK ABSCESS DRAINAGE SET HAD INSUFFICIENT DRAINAGE. THE DEVICE WAS REQUIRED FOR A STUDY PROCEDURE (MDR-1919) AND WAS PLACED ON (B)(6) 2021 FOR ABSCESS DRAINAGE FOR A LEFT SIDE PNEUMOTHORAX. DILATION WAS PERFORMED PRIOR TO CATHETER PLACEMENT AND COMPUTED TOMOGRAPHY (CT) WAS UTILIZED FOR VISUAL GUIDANCE DURING THE PROCEDURE. THE DRAINAGE CATHETER WAS SUCCESSFULLY PLACED AND DRAINAGE WAS ESTABLISHED. HOWEVER, COMPLETE FLUID EVACUATION WAS NOT ACHIEVED WITH THIS DEVICE. SIX DAYS POST PLACEMENT, ON (B)(6) 2021, THE DEVICE WAS REMOVED DUE TO INSUFFICIENT DRAINAGE. THE PATIENT THEN REQUIRED VIDEO ASSISTED THORACOSCOPIC SURGERY (VATS) AND PLEURODESIS TO RESOLVE THE PNEUMOTHORAX. NO ADVERSE WERE REPORTED PRIOR TO THE PATIENT EXITING THE STUDY.

  Patient problems: Failure of Implant

  MAUDE report 14959639 ↗
• InjuryJul 8, 2022Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  IT WAS REPORTED THAT A THAL-QUICK ABSCESS DRAINAGE SET DID NOT DRAIN WELL. THE DEVICE WAS REQUIRED FOR A STUDY PROCEDURE (MDR-1919) AND WAS PLACED ON (B)(6) 2021 FOR ABSCESS DRAINAGE OF A LEFT PLEURAL EFFUSION. DILATION WAS PERFORMED PRIOR TO PLACEMENT OF THE CATHETER AND FLUOROSCOPY AND ULTRASOUND GUIDED THE PROCEDURE. THE CATHETER WAS PLACED SUCCESSFULLY AND DRAINAGE WAS ESTABLISHED. HOWEVER, COMPLETE FLUID EVACUATION WAS NOT ACHIEVED WITH THIS DEVICE AS THE "LOCULATED FLUID" DID NOT DRAIN WELL. THE CATHETER WAS REMOVED ON (B)(6) 2021 AND A VIDEO ASSISTED THORACOSCOPIC SURGERY (VATS) WAS REQUIRED FOR DRAINAGE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Failure of Implant

  MAUDE report 14959570 ↗