Dawson Mueller G11386Recalls & reported problems
Cook Incorporated · Dawson-Mueller Drainage Catheter 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002113862), received between Nov 9, 2017 and Sep 25, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (3 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove3
- Gas/Air Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897731 ↗MalfunctionFeb 24, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE INNER STIFFENER OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE. WHILE PERFORMING A NEPHROSTOMY, THE RADIOLOGIST ATTEMPTED TO REMOVE THE INNER STIFFENER FROM THE CATHETER AND THE ENTIRE CATHETER "BUNCHED UP (CONCERTINA EFFECT)" IN RETURN. ANOTHER CATHETER WAS USED AND PLACED, SUCCESSFULLY. 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 16436502 ↗MalfunctionJan 27, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE METAL STIFFENER WITHIN AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER COULD NOT BE WITHDRAWN FROM THE CATHETER. A (B)(6), MALE PATIENT PRESENTED FOR AN ULTRASOUND GUIDED DRAINAGE OF ABDOMINAL WALL COLLECTION. AFTER ADVANCING THE DEVICE INTO PLACE, THE METAL STYLET WOULD NOT DETACH FROM THE CATHETER. A NEW CATHETER WAS OPENED AND USED TO SUCCESSFULLY 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 13371139 ↗InjuryDec 12, 2019Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED A FEMALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR AN LEFT AXILLA ABSCESS DRAINAGE PROCEDURE. AFTER PLACEMENT, THE OPERATOR NOTICED "THE DRAIN COULD NOT MAINTAIN A SEAL AND SO SUCTION WAS NOT POSSIBLE". THE DRESSING WAS REINFORCED AND THE DEVICE WAS KEPT "INSITU FOR A FEW HOURS". SUCTION WAS NOT ACHIEVED, SO THE DRAIN WAS REPLACED WITH A NEW SIMILAR DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Code Available
MAUDE report 9460018 ↗MalfunctionNov 9, 2017Leak/Splash
IT WAS REPORTED THAT THE DEVICE WAS PLACED AND STITCHED TO THE PATIENT WITH THE BAG, LEAKAGE OF BODY FLUID WAS NOTED FROM THE WHITE PLASTIC AREA. THE DEVICE WAS REPLACED.
Patient problems: No Information
MAUDE report 7013877 ↗
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.
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