Dawson MuellerRecalls & reported problems across all models
Cook Incorporated · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 512
- Deaths reported
- 2
- Injuries reported
- 103
- Recalls
- 0
We found 14 models of Dawson Mueller by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 512 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2015 and Sep 29, 2026 — classified as 2 deaths, 103 injuries, 407 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (153 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Dawson Mueller problems
Device problems
- Leak/Splash153
- Fluid/Blood Leak86
- Difficult to Remove72
- Material Separation44
- Air Leak27
- Detachment of Device or Device Component25
- Detachment Of Device Component21
- Gas/Air Leak16
Patient problems
- No Known Impact Or Consequence To Patient192
- No Clinical Signs, Symptoms or Conditions123
- No Code Available73
- No Consequences Or Impact To Patient53
- No Patient Involvement39
- Insufficient Information11
- Pain8
- Foreign Body In Patient7
Dawson Mueller models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dawson Mueller G09705CATHETER, NEPHROSTOMY2 deaths215 reports
- Dawson Mueller G11020CATHETER, NEPHROSTOMY100 reports
- Dawson Mueller G13768CATHETER, NEPHROSTOMY59 reports
- Dawson Mueller G09706CATHETER, NEPHROSTOMY31 reports
- Dawson Mueller G13766CATHETER, NEPHROSTOMY25 reports
- Dawson Mueller G10435CATHETER, NEPHROSTOMY21 reports
- Dawson Mueller G51595CATHETER, NEPHROSTOMY15 reports
- Dawson Mueller G27298CATHETER, NEPHROSTOMY13 reports
- Dawson Mueller G51594CATHETER, NEPHROSTOMY10 reports
- Dawson Mueller G10436CATHETER, NEPHROSTOMY8 reports
- Dawson Mueller G11386CATHETER, NEPHROSTOMY5 reports
- Dawson Mueller G30027CATHETER, NEPHROSTOMY5 reports
- Dawson Mueller G13765CATHETER, NEPHROSTOMY4 reports
- Dawson Mueller G11018CATHETER, NEPHROSTOMY1 report
Recent Dawson Mueller adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Remove
It was reported that the stiffening cannula could not be removed from an Ultrathane Dawson-Mueller Mac-Loc Locking Loop Multipurpose Drainage Catheter during an unspecified procedure.The drainage catheter with stiffener were advanced over the wire guide; however, when attempting to remove the stiffening cannula, it was found to be firmly lodged in the catheter and could not be removed. Another device was subsequently used, but the stiffening cannula of that device also could not be removed. The procedure was completed using an alternative like device from a different catalog number.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 50935629 ↗MalfunctionSep 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897731 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
It was reported that suture of an Ultrathane Dawson-Mueller Mac-Loc locking Loop Multipurpose Drainage Catheter broke. During an unknown procedure, the Mac-Loc hub assembly was held firmly with one hand while the locking suture was pulled backwards with the other hand to form the pigtail loop at the distal end of the catheter. No "obvious jamming" was experienced when pulling the suture and pushing down the locking lever. Upon applying additional force, the suture broke. Another drainage catheter from a different lot was 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.Upon inspection of the returned catheter, Cook discovered the catheter tip was torn, thus prompting this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889046 ↗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 ↗MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164453 ↗MalfunctionJul 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED AIR/FLUID. THE USER DISCONTINUED ITS USE AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE FROM HOSPITAL STOCK. 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 25720286 ↗MalfunctionJul 1, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. THE LEAKAGE WAS NOTED AFTER PLACEMENT. THEREFORE, THE LEAKING DRAINAGE CATHETER WAS REMOVED, AND A NEW DRAINAGE CATHETER WAS INSERTED BEFORE COMPLETION OF THE PROCEDURE. THE PHYSICIAN CUT OFF THE CATHETER SHAFT OF THE DEVICE AND DISCARDED, ONLY LEAVING THE HUB OF THE DEVICE FOR EVALUATION. 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 25681394 ↗MalfunctionJun 18, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DAMAGED. THE DEVICE HAD PLANNED TO BE USED FOR A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE. HOWEVER, WHEN ATTEMPTING TO PLACE THE DEVICE AFTER INSERTING THE TROCAR, A POSSIBLE CRACK WAS OBSERVED AT THE DISTAL TIP OF THE CATHETER. THEREFORE, THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED 8.5 FR DRAINAGE CATHETER. THE USER COMMENTED THAT THE TIMING OF THE CRACK OCCURRENCE IS UNKNOWN, POSSIBLY OCCURRING WHEN THE ASSISTANT INSERTED THE TROCAR. HOWEVER, IT DID NOT APPEAR BY THE USER TO BE CONSISTENT WITH TYPICAL DAMAGE CAUSED DURING SUCH HANDLING. 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 25551558 ↗MalfunctionJun 16, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO INSERT DURING A LIVER ABSCESS DRAINAGE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE COOK PIGTAIL DRAINAGE CATHETER. THE DEVICE WAS RECEIVED 09JUN2026, REVEALING A TEAR IN THE CATHETER TIP AND A SEPARATED SUTURE. THUS, PROMPTING THIS REPORT. 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 25522776 ↗MalfunctionMar 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. UPON INSERTION OF THE CATHETER, NO FLUID COULD BE ASPIRATED DUE TO A LEAK IDENTIFIED AT THE CATHETER HUB. THIS LEAK PREVENTED THE RETURN OF SECRETION THROUGH THE CATHETER. ANOTHER LIKE DEVICE 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 24620620 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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