Dawson Mueller G30027Recalls & reported problems
Cook Incorporated · Dawson Mueller Drainage Set Ultrathane · Class U · Implant
All models of Dawson Mueller (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002300279), received between Nov 13, 2017 and Mar 4, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- Leak/Splash2
- Air Leak1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED AN ULTRATHANE MULTIPURPOSE DRAINAGE SET LEAKED. THE CATHETER WAS ADVANCED INTO THE BILE DUCT USING SELDINGER TECHNIQUE. THEN, A LEAK BETWEEN THE HUB AND CATHETER TUBING WAS DISCOVERED. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. 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 13672935 ↗MalfunctionJan 3, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MULTIPURPOSE DRAINAGE SET DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE EXCHANGE PROCEDURE. THE OPERATOR REPORTED THE DRAINAGE DEVICE WAS INSERTED IN THE BODY OVER THE WIRE GUIDE. WHEN ATTEMPTING TO REMOVE THE WIRE FROM THE CATHETER, "THE WIRE GUIDE GOT CAUGHT IN THE PIG TAIL." THE WIRE WAS REMOVED FROM THE CATHETER "SOMEHOW" AND "THE CATHETER WAS PLACED IN THE BODY". AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9546432 ↗MalfunctionOct 24, 2018Material Integrity Problem; Material Integrity Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8000044 ↗MalfunctionNov 14, 2017Leak/Splash
AFTER PLACING THE CATHETER, LEAKAGE FROM CONNECTION BETWEEN THE HUB AND CATHETER WAS CONFIRMED. IT WAS REPLACED WITH ANOTHER DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7028856 ↗MalfunctionNov 13, 2017Air Leak
IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO PERFORM DRAINAGE WITH THE CATHETER, ONLY AIR WAS ASPIRATED. THE PHYSICIAN EXAMINED THE DEVICE AND FELT THAT AIR WAS LEAKING BETWEEN CATHETER AND HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7024593 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page