Dawson Mueller G11020Recalls & reported problems
Cook Incorporated · Dawson-Mueller Drainage Catheter Ultrathane · Class U · Implant
Quick summary
This Dawson-Mueller drainage catheter has 100 adverse event reports mentioning 18 injuries and no deaths. Reports mostly describe leaks, material separation, detachment and breaks, sometimes leading to replacement. There are no recalls for this device. Report volume fell from 6 to 1 in the last 12 months compared with the prior year.
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
- 100
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00827002110205), received between Jan 20, 2015 and Sep 24, 2026 — classified as 18 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (41 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
- Leak/Splash41
- Fluid/Blood Leak31
- Difficult to Remove9
- Material Separation7
- Detachment of Device or Device Component3
- Break2
- Air Leak1
- Complete Blockage1
Patient problems
- No Known Impact Or Consequence To Patient48
- No Clinical Signs, Symptoms or Conditions14
- No Code Available14
- No Consequences Or Impact To Patient11
- No Patient Involvement11
- Device Embedded In Tissue or Plaque1
- Fluid Discharge1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350873 ↗InjuryOct 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 23286247 ↗MalfunctionSep 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER HAD FOREIGN MATTER WITHIN THE PACKAGING. WHEN THE DOCTOR PREPARED TO USE THE DEVICE, HE BEGAN BY PUSHING A "FOAM" CATHETER TO STRAIGHTEN IT. HE REMOVED THE "FOAM TIP" AND INSERTED THE NEEDLE. HE NOTICED TWO CLEAR PLASTIC PIECES AT THE END OF THE NEEDLE, AND ANOTHER ONE POSITIONED AT THE CATHETER¿S OPENING. THE CATHETER ITSELF WAS WHITE IN COLOR. HE PLACED ALL THE PLASTIC COMPONENTS INTO A STERILE CONTAINER FOR FURTHER EXAMINATION. 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 22962794 ↗MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MUTLIPURPOSE DRAINAGE CATHETER CRACKED. THE CATHETER WAS PLACED ON (B)(6) 2025 FOR BILIARY TRACT DRAINAGE. ONE DAY AFTER PLACEMENT, BILE DRAINAGE WAS FOUND TO BE OBSTRUCTED. THE DRAINAGE CATHETER WAS TESTED WITH FLUID INJECTION, AND A CRACK WAS REVEALED. THE PATIENT DECLINED CATHETER REPLACEMENT; THEREFORE, THE PORTION OF THE DRAIN EXTERNAL TO THE BODY WAS "TREATED". A CUSTOMER PROVIDED PHOTO SHOWS LEAKING OF FLUID AROUND THE MAC-LOC HUB. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956612 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE WAS IDENTIFIED AT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) FOR A 56-YEAR-OLD MALE PATIENT. THE PROCEDURE WENT SMOOTHLY WITHOUT ANY DAMAGE TO THE MAC-LOC ASSEMBLY. THE PHYSICIAN INDICATED THAT THE LEAK WOULD BE MONITORED CONTINUOUSLY, WITH THE POSSIBILITY OF REMOVAL AND REPLACEMENT IF NECESSARY. AT THIS TIME, THE DEVICE REMAINS IN THE PATIENT. NO ADDITIONAL HARM HAS BEEN REPORTED. THE FACILITY PLANS TO RETURN THE DEVICE TO THE MANUFACTURER FOR INVESTIGATION UPON REMOVAL FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777408 ↗InjuryAug 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 22730362 ↗MalfunctionJan 16, 2024Difficult to Remove; Difficult to Remove
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 18519853 ↗MalfunctionMay 17, 2023Difficult to Remove; Difficult to Remove
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 16948095 ↗MalfunctionFeb 14, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
IT WAS REPORTED THAT THE METAL STIFFENER OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO ADVANCE. AFTER THE DRAINAGE CATHETER WAS RINSED WITH NORMAL SALINE, IT WAS DISCOVERED THAT THE METAL STIFFENER WAS DIFFICULT TO ADVANCE THROUGH THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, A NEW DEVICE WAS OBTAINED 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 RECEIPT OF THE COMPLAINT DEVICE, COOK DISCOVERED THAT THE METAL STIFFENER WAS LODGED INSIDE THE CATHETER AND WAS DIFFICULT TO REMOVE, THUS PROMPTING THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16373599 ↗MalfunctionNov 8, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED AN 82-YEAR-OLD, 60 KG MALE PATIENT REQUIRED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR AN UNSPECIFIED PROCEDURE. THE BILE DUCT WAS PUNCTURED WITH A 21-GAUGE NEEDLE. AFTER REMOVING THE GUIDING SHEATH, ADVANCING THE DRAINAGE CATHETER ALONG THE WIRE GUIDE, AND FLUSHING THE DEVICE, THE CATHETER COULD NOT BE SEPARATED OR REMOVED FROM THE NEEDLE CORE. AFTER MANY ATTEMPTS AND APPLYING A LARGE AMOUNT OF EXTERNAL FORCE, THE DRAINAGE CATHETER BECAME DEFORMED. THE DEVICE WAS REMOVED, 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 15756071 ↗MalfunctionJun 22, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS INITIALLY REPORTED THAT THE "BROWN BLUNT END STYLET" OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER HAD BROKEN DURING REMOVAL. THE CATHETER AND THE BROKEN END OF THE STYLET WERE IMMEDIATELY REMOVED AND A NEW 7 FRENCH CATHETER SET WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND IT WAS CONFIRMED THAT THE COMPONENT THAT HAD BROKEN WAS THE METAL STIFFENING CANNULA. ADDITIONAL INFORMATION WAS PROVIDED ON 17JUN2022 INDICATING THAT THE METAL STIFFENING CANNULA WAS DIFFICULT TO REMOVE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14780627 ↗MalfunctionOct 27, 2021Difficult to Remove; Difficult to Remove
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 12706325 ↗MalfunctionMay 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
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 11890502 ↗MalfunctionMar 31, 2021Leak/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 11598907 ↗InjuryFeb 19, 2021Detachment 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 Code Available
MAUDE report 11353344 ↗MalfunctionJul 23, 2020Leak/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 Known Impact Or Consequence To Patient
MAUDE report 10314393 ↗MalfunctionJul 23, 2020Leak/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 Known Impact Or Consequence To Patient
MAUDE report 10314240 ↗MalfunctionJan 6, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED A (B)(6) YEAR-OLD FEMALE PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR THE DRAINAGE OF A RIGHT RENAL CYST. THE OPERATOR REPORTED THAT AFTER THE CATHETER WAS PLACED INTO THE SAC OF THE RENAL CYST, THE CATHETER DID NOT WITHDRAWAL ANY LIQUID. THE OPERATOR REPORTED USING ULTRASOUND TO CONFIRM PROPER PLACEMENT AND ALSO ATTEMPTED TO REMOVE "THE CATHETER AND INSERT IT MANY TIMES ALONG WIRE GUIDE, BUT IT STILL FAILED." THE CATHETER WAS THEN REMOVED AND THE PHYSICIAN PROCEEDED TO COMPLETE THE PROCEDURE UTILIZING A NEEDLE, WHICH WAS SUCCESSFUL BUT RESULTED IN AN INCREASE IN PROCEDURE TIME. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 9554303 ↗InjuryJan 2, 2020Material Separation; Material Separation
IT WAS REPORTED A FEMALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR DRAINAGE PROCEDURE. A WEEK AFTER PLACEMENT, THE MAC-LOC "TIP OF THE CATHETER NEAR THE HUB" WAS DETACHED FROM THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT SUCCESSFULLY, AND THE PHYSICIAN REPLACED IT WITH ANOTHER NEW, SIMILAR DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Code Available
MAUDE report 9540111 ↗MalfunctionDec 31, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9536117 ↗InjuryDec 12, 2019Leak/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 Code Available
MAUDE report 9460371 ↗MalfunctionDec 9, 2019Material Separation; Material Separation
IT WAS REPORTED THAT AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER AS A NEPHROSTOMY TUBE FOR EXTERNAL DRAINAGE (UNKNOWN WHICH KIDNEY). AFTER PLACEMENT, THE OPERATOR REPORTED "THE FINAL PLASTIC PIECE IS BROKEN OR GO AWAY." THE OPERATOR REPORTS PLACING THREE DEVICES FROM THE SAME LOT NUMBER DURING THIS PROCEDURE WITH THE SAME FAILURE OCCURRING. 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 9438672 ↗MalfunctionDec 2, 2019Leak/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 Known Impact Or Consequence To Patient
MAUDE report 9397873 ↗MalfunctionDec 2, 2019Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9397764 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.