Cook G05297Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002052970), received between Sep 21, 2018 and Oct 28, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “No Flow” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Leak/Splash; Leak/Splash

  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 20549790 ↗
• MalfunctionJun 6, 2023Deformation Due to Compressive Stress; Material Deformation; Packaging Problem; Deformation Due to Compressive Stress; Material Deformation; Packaging Problem

  IT WAS REPORTED THE VINYL CONNECTING TUBES OF SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SETS ORDERED WERE BENT. PER CUSTOMER, THE DEVICES WERE RECEIVED AND PACKED BY THE VENDOR IN WHICH THE DEVICES WERE FOLDED TO FIT IN A BAG AND BE USED AS A "KIT." DUE TO HOW THE DEVICES WERE PACKED, THE VINYL CONNECTING TUBES BECAME BENT AND WERE NOT ABLE TO BE USED. NO PATIENT CONTACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069812 ↗
• MalfunctionSep 30, 2022No Flow; No Flow

  ONE UNUSED CHEST DRAIN VALVE FROM A SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SET WAS RETURNED TO COOK. IT WAS REPORTED THAT THE VALVE LEAFLETS WERE ADHERED TO THEMSELVES PREVENTING AIR FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518745 ↗
• MalfunctionSep 30, 2022No Flow; No Flow

  TWO UNUSED AND ONE PRIOR TO USE CHEST DRAIN VALVES FROM SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SETS WERE RETURNED TO COOK. IT WAS REPORTED THAT THE VALVE LEAFLETS WERE ADHERED TO THEMSELVES PREVENTING AIR FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518743 ↗
• MalfunctionSep 30, 2022No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518657 ↗
• MalfunctionSep 30, 2022No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518643 ↗
• MalfunctionSep 30, 2022No Flow; No Flow

  THREE UNUSED CHEST DRAIN VALVES FROM SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SETS WERE RETURNED TO COOK. IT WAS REPORTED THAT THE VALVE LEAFLETS WERE ADHERED TO THEMSELVES PREVENTING AIR FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518628 ↗
• MalfunctionSep 30, 2022No Flow; No Flow

  TWO UNUSED CHEST DRAIN VALVES FROM SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SETS WERE RETURNED TO COOK. IT WAS REPORTED THAT THE VALVE LEAFLETS WERE ADHERED TO THEMSELVES PREVENTING AIR FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514495 ↗
• MalfunctionSep 16, 2022No Flow; No Flow

  IT WAS REPORTED THAT TWO CHEST DRAIN VALVES FROM SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SETS DID NOT PROVIDE AIR FLOW DURING A TABLE TOP TEST. THE DEVICES WERE CONNECTED TO MEASURED AIR FLOW BY A CLINICAL ENGINEER; HOWEVER NO FLOW WAS OBSERVED. AS REPORTED, THE VALVE LEAFLETS WERE ADHERED TO THEMSELVES PREVENTING FLOW. THE FLOW WAS THEN INCREASED AND THE VALVES "POPPED OPEN". ONE DEVICE STILL SHOWED ADHESION IN THE CORNER OF THE VALVE AFTER RECEIVING "12 CM H20 PRESSURE THROUGH IT TO POP IT OPEN". FURTHER COMMUNICATION WITH THE CUSTOMER PROVIDED PHOTOS OF THE TESTING AND DEVICES. IT WAS CONFIRMED THAT THE DEVICE WAS APPLIED IN THE CORRECT ORIENTATION. IT WAS ALSO NOTED THAT "SEASONED PERSONNEL" PLACED THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442163 ↗
• MalfunctionSep 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED DURING INCOMING INSPECTION FOREIGN MATTER, BLACK PARTICLE, WAS FOUND INSIDE THE PRIMARY PACKAGING OF A SEALED SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SET. AS REPORTED, THIS DEVICE ISSUE WAS DISCOVERED DURING INSPECTION; THEREFORE, IT DID NOT MAKE CONTACT WITH THE USER OR PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7899142 ↗