Cook G03302Recalls & reported problems
Cook Incorporated · Pneumothorax Set · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002033023), received between May 12, 2017 and Feb 6, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Defective Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 21326728 ↗InjuryOct 8, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER INCLUDED IN THE COOK PNEUMOTHORAX SET BROKE AT THE HUB DURING A PROCEDURE IN THE CHEST ON A PATIENT OF UNKNOWN AGE AND GENDER. THE PATIENT HAD THE PRODUCT IN PLACE AND STAFF OBSERVED THAT THE END WAS BEGINNING TO LOOSEN. THE CUSTOMER LATER CAME BACK AND REPORTED THAT THE HUB BROKE OFF. THE DEVICE WAS INSIDE THE PATIENT AND UPON INSPECTION, THE BREAKAGE WAS CLEARLY VISIBLE. THE PATIENT REQUIRED A NEW CHEST DRAIN. A NEW DEVICE WAS INSERTED BY REPLACING THE BROKEN DEVICE WITH A NEW ONE OVER THE GUIDE WIRE IN AN ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20401845 ↗InjuryMay 12, 2017Defective Component; Defective Component
PER THE USER FACILITY MEDWATCH REPORT IT WAS STATED THAT WHILE EDP USING THE COOK BRAND PNEUMO DART, HE WAS NOT ABLE TO THREAD CATHETER OFF THE GUIDE NEEDLE. HE STOPPED PROCEDURE AND ACTUALLY HAD TO USE QUITE A BIT OF STRENGTH AND A HEMOSTAT TO REMOVE FROM NEEDLE. PATIENT THEN WAS SENT TO CT FOR INSERTION OF CHEST TUBE. NO UNINTENDED SECTION OF THE DEVICE REMAINED WITHIN THE PATIENT.
Patient problems: No Code Available
MAUDE report 6563503 ↗
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- Argyle 10142Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12191Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Medline Industries, Inc. OR929KMedline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12102Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 10102Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.