Dawson Mueller G09705Recalls & reported problems
Cook Incorporated · Dawson-Mueller Drainage Catheter Ultrathane · Class U · Implant
All models of Dawson Mueller (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Ultrathane Dawson-Mueller drainage catheter is used to drain fluid from the body. Its 215 reports include 49 injuries and 2 deaths. Many reports describe leaking, often at the hub, and some describe catheters that are hard to remove or have parts come apart. Many reports note no effect on the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 215
- Deaths reported
- 2
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 00827002097056), received between Jul 29, 2016 and Aug 11, 2026 — classified as 2 deaths, 49 injuries, 164 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (70 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash70
- Difficult to Remove35
- Air Leak21
- Fluid/Blood Leak20
- Material Separation15
- Detachment Of Device Component12
- Break7
- Detachment of Device or Device Component7
Patient problems
- No Known Impact Or Consequence To Patient73
- No Clinical Signs, Symptoms or Conditions49
- No Code Available32
- No Consequences Or Impact To Patient29
- No Patient Involvement13
- Pain6
- Insufficient Information5
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 25 most recent of 215 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Detachment of Device or Device Component
It was reported that the Mac-Loc hub detached from an Ultrathane Dawson-Mueller Mac-Loc Locking Loop Multipurpose Drainage Catheter during a drainage procedure. the procedure was completed with a new unspecified product.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 50206493 ↗MalfunctionFeb 13, 2026Difficult to Remove
IT WAS REPORTED THAT THE METAL STIFFENING CANNULA COULD NOT BE REMOVED FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE DIRECT STICK TECHNIQUE WAS USED TO PLACE THE DRAINAGE CATHETER DURING A GALLBLADDER CATHETERIZATION (OR A PERCUTANEOUS CHOLECYSTOSTOMY) PROCEDURE IN A 73-YEAR-OLD FEMALE PATIENT WITH CHOLECYSTITIS. AFTER THE DIRECT STICK, THE CANNULA COULD NOT BE REMOVED FROM THE CATHETER. THE ASSEMBLY WAS REMOVED TOGETHER FROM THE PATIENT, AND A NEW DRAINAGE CATHETER WAS USED 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 24337351 ↗InjuryFeb 3, 2026Obstruction of Flow
IT WAS REPORTED THAT COOK ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS WERE "BLOCKING." AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24246794 ↗InjuryFeb 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT COOK ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS WERE LEAKING. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24245752 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE FROM THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS OBSERVED DURING INSERTION FOR AN UNKNOWN PATIENT. THE PROCESS OF INSERTION WAS THEN REPEATED DURING THE SAME PROCEDURE. 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 24201251 ↗InjuryJan 2, 2026Break
IT WAS REPORTED THAT "DURING NORMAL USE" THE SUTURE THREAD OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN PLACE IN THE 60-YEAR-OLD MALE PATIENT PRIOR TO THE SUTURE BREAKING. IT WAS SAID THAT THIS OCCURRENCE LED TO ACCUMULATION OF FLUID AND BLOOD, RESULTING IN LOCAL SWELLING, THAT NEEDED TO BE EXTRACTED. A NEW DRAINAGE CATHETER WAS PLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Swelling/ Edema
MAUDE report 23945999 ↗MalfunctionAug 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AFTER BEING PLACED FOR ABDOMINAL ABSCESS DRAINAGE, THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED FROM THE HUB. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAIL HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912915 ↗InjuryJul 28, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 22630490 ↗MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IN ADDITIONAL INFORMATION RECEIVED ON 28APR2025, IT WAS CONFIRMED THAT THE DEVICE WAS IN PLACE FOR LESS THAN 30 SECONDS BEFORE THE LEAKAGE WAS DISCOVERED. THE SYRINGE WITH CONTRAST WAS ATTACHED TO THE HUB OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21911027 ↗MalfunctionFeb 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS NOTED IN THE SEALED INTERNAL PACKAGING OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE DEVICE MADE NO PATIENT CONTACT. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425055 ↗InjuryJan 14, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IN ADDITIONAL INFORMATION RECEIVED ON 27JAN2025, IT WAS REPORTED THAT WHEN THE PATIENT WENT TO THE BATHROOM, THE CATHETER SEPARATED IN TWO PIECES. HALF OF THE CATHETER CAME OFF AND THE OTHER HALF WAS RETAINED IN THE PELVIS OF THE PATIENT. THE RETAINED PORTION OF THE CATHETER WAS THEN REMOVED FROM THE PATIENT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON 05FEB2025. IT WAS CONFIRMED DURING PRELIMINARY DEVICE FAILURE ANALYSIS THAT THE SHAFT OF THE CATHETER HAD SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21151974 ↗MalfunctionJan 8, 2025Difficult to Remove; No Apparent Adverse Event; Difficult to Remove; No Apparent Adverse Event
IN ADDITIONAL INFORMATION RECEIVED ON 15JAN2025, IT WAS CONFIRMED THAT THERE WAS NO DIFFICULTY ADVANCING AND REMOVING THE METAL CANNULA FROM THE CATHETER NOR THE TROCAR STYLET THROUGH THE METAL CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103959 ↗MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT, AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21034493 ↗MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED AND LEAKED DURING PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE ON A PATIENT OF AN UNKNOWN AGE AND GENDER. A LEAK WAS OBSERVED WHILE FLUSHING THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS THAT THE HUB SEPARATED FROM THE CATHETER SHAFT. 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 20463925 ↗MalfunctionJul 22, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; 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 19794141 ↗MalfunctionJul 8, 2024Break; Break
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689582 ↗InjuryJun 24, 2024Material Puncture/Hole; Material Puncture/Hole
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 19595284 ↗MalfunctionMay 16, 2024Contamination; Contamination
IT WAS REPORTED THAT THE INNER STERILE PACKAGING OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS NOTED TO HAVE A SMALL UNKNOWN BLUE STAIN. THIS WAS NOTED PRIOR TO USE, AND THE DEVICE WAS NOT USED. ANOTHER CATHETER WAS USED 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 19334954 ↗MalfunctionMay 10, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE LOCKING OF AN 'ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER' WAS "FIXED AND NOT MOVING". NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT HAVE BEEN REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293345 ↗MalfunctionMar 8, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE METAL STIFFENING CANNULA COULD NOT BE REMOVED FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING AN ULTRASOUND-GUIDED GALLBLADDER PUNCTURE CATHETER DRAINAGE PROCEDURE. THE DRAINAGE CATHETER AND STIFFENING CANNULA WERE PLACED OVER A WIRE GUIDE, AND THEN COULD NOT BE SEPARATED. THE DRAINAGE CATHETER AND STIFFENING CANNULA WERE REMOVED, AND A NEW DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT EXPERIENCED NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870816 ↗MalfunctionFeb 1, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE METAL STIFFENING CANNULA OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE. THE DEVICE WAS REQUIRED FOR A RIGHT PERCUTANEOUS NEPHROSTOMY DRAIN PLACEMENT, AND THE CATHETER WAS ADVANCED INTO THE PATIENT USING SELDINGER TECHNIQUE. DURING ATTEMPTED REMOVAL OF THE STIFFENING CANNULA FROM THE CATHETER, THE CANNULA STUCK TO THE TIP OF THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT, AND SLIGHT BLEEDING OCCURRED. AFTER THE CATHETER WAS REMOVED, CRIMPING OF THE CATHETER WAS OBSERVED WHEN REMOVAL OF THE STIFFENER WAS ATTEMPTED. FINALLY, A DIFFERENT DEVICE WAS OBTAINED 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: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18626459 ↗InjuryJan 2, 2024Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS FOUND TO BE LEAKING. THREE DAYS AFTER PLACEMENT INTO THE PATIENT FOR BILIARY DRAINAGE, THE DRAINAGE TUBE COULD NOT LEAD OUT BILE. THE DOCTOR FLUSHED THE CATHETER WITH SALINE BUT DISCOVERED A LEAK AT THE CONNECTION BETWEEN THE CATHETER HUB AND THE CATHETER SHAFT. IT WAS FOUND THAT THE SALINE COULD NOT BE FLUSHED OUT. THE COMPLAINT DEVICE WAS THEN REMOVED AND REPLACED WITH A NEW LIKE-DEVICE. IT WAS CONFIRMED DURING CONTRAST EXAMINATION THAT THE CONTRAST SOLUTION WAS VISIBLE AT THE JUNCTION BETWEEN THE CATHETER HUB AND THE CATHETER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18427033 ↗InjuryDec 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. THE DEVICE WAS REQUIRED FOR PERCUTANEOUS TRANSHEPATIC CHOLANGIO DRAINAGE AND WAS PLACED IN THE COMMON BILE DUCT (CBD). TWO DAYS AFTER THE PROCEDURE, THE CATHETER WAS FOUND LEAKING BY AN INTENSIVE CARE UNIT (ICU) NURSE. SUBSEQUENTLY, AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE AND REPLACE THE CATHETER. 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 18315195 ↗MalfunctionNov 17, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
ADDITIONAL INFORMATION WAS PROVIDED. AS REPORTED, THE DEVICE WAS PLACED IN THE PATIENT'S KIDNEY. THE LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161066 ↗MalfunctionNov 9, 2023Leak/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 18103823 ↗
Other CATHETER, NEPHROSTOMY devices
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- 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
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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