Dawson Mueller G09706Recalls & 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 Medical Dawson-Mueller Ultrathane drainage catheter is a soft tube used to drain fluid from the body, such as after a nephrostomy procedure. Most of the 31 reports describe the catheter leaking fluid or air, or parts of it coming apart, and a few mention particles found inside the sterile packaging before use. Nine reports describe injuries; no deaths were reported. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002097063), received between Sep 22, 2016 and Aug 6, 2026 — classified as 9 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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/Splash8
- Material Separation6
- Detachment of Device or Device Component3
- Device Contaminated During Manufacture or Shipping3
- Fluid/Blood Leak3
- Air Leak2
- Detachment Of Device Component2
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Code Available7
- No Known Impact Or Consequence To Patient7
- Insufficient Information3
- No Consequences Or Impact To Patient3
- Failure of Implant1
- No Patient Involvement1
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164453 ↗MalfunctionJan 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A FOREIGN PARTICLE WAS FOUND INSIDE THE STERILE PACKAGING OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE FOREIGN PARTICLE WAS DISCOVERED DURING GENERAL INSPECTION. 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 18573106 ↗InjuryNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. AN UNKNOWN PATIENT HAD A NEPHROSTOMY DRAINAGE PROCEDURE COMPLETED WITHOUT INCIDENT IN RADIOLOGY AND WAS RETURNED TO THE WARD. THE STAFF NOTICED LEAKAGE AT THE HUB AND TUBE CONNECTION OF THE DEVICE. THE DEVICE WAS ADJUSTED AND FIXED WHILE IN THE PATIENT AND WAS LEFT IN SITU AS PLANNED. THE PATIENT WAS DISCHARGED THE SAME DAY. 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 18133929 ↗MalfunctionAug 2, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. AFTER THE DEVICE WAS PLACED IN THE PATIENT, IT WAS NOTED THAT THE COLLECTION BULB ATTACHED TO THE DRAIN WAS SLOWLY LOSING SUCTION. THE BULB WAS REPLACED. LATER, IT WAS REPORTED THAT THE BULB WAS STILL LOSING SUCTION OVER THE PERIOD OF AN HOUR. AS A RESULT, THE DRAIN WAS REMOVED ON (B)(6) 2023. THE CUSTOMER PLACED THE CATHETER IN A CONTAINER OF WATER TO TEST FOR A LEAK. A PHOTO WAS PROVIDED SHOWING A LEAK BETWEEN THE CATHETER CAP AND MAC-LOC HUB. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17443949 ↗MalfunctionJun 26, 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 17203883 ↗MalfunctionApr 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A "BLACK FUZZY PARTICLE" WAS NOTICED INSIDE THE UNOPENED PACKAGE OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THIS OCCURRENCE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777485 ↗MalfunctionOct 28, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 15691164 ↗InjuryJul 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A MALE PATIENT REQUIRED REPLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE CATHETER WAS INITIALLY PLACED IN THE PATIENT DURING A NEPHROSTOMY EXCHANGE AND CONNECTED TO DRAINAGE BAG. A WIRE GUIDE WAS INTRODUCED TO REMOVE THE PREVIOUS CATHETER AND A THE COMPLAINT DEVICE WAS PLACED OVER THE WIRE. THE FOLLOWING DAY AFTER PLACEMENT, THE PATIENT RETURNED TO THE FACILITY WITH CONFIRMED LEAKING AT THE CATHETER HUB. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED. IT SHOULD BE NOTED, THE USER DENIED ANY FORCED EXERTION ON THE CATHETER AND CONFIRMED THE FITTING WAS SECURELY ATTACHED ON FIRST INSPECTION. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Failure of Implant
MAUDE report 15089097 ↗MalfunctionOct 14, 2021Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE DURING A PERCUTANEOUS DRAINAGE PROCEDURE ON AN UNKNOWN PATIENT. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631783 ↗MalfunctionJul 1, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THE CATHETER HAD AN AIR LEAK. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12102874 ↗MalfunctionJul 1, 2021Material Separation; Material Separation
THE DEVICE WAS RETURNED ON 20JUL2021 AND SHOWED A BEND IN THE METAL STIFFENER.
Patient problems: Insufficient Information
MAUDE report 12101256 ↗InjuryApr 29, 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: Pneumothorax
MAUDE report 11749175 ↗MalfunctionApr 13, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS PROVIDED ON 28JUN2021. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A DRAIN OF THE SAME SIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11655643 ↗MalfunctionMar 17, 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 11506681 ↗MalfunctionNov 6, 2019Difficult to Advance; Difficult to Advance
IT WAS ORIGINALLY REPORTED THAT 4 DEVICES OF THIS LOT EXPERIENCED THIS FAILURE. THE FACILITY RETURNED AN ADDITIONAL PRIOR TO USE DEVICE WITH THE STYLET LOADED INTO THE CATHETER. THEREFORE, THE FACILITY NOTED THIS OCCURRENCE ON FIVE DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9286790 ↗MalfunctionSep 19, 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 9088496 ↗MalfunctionAug 28, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED INTO THE BILIARY DUCT OF A PATIENT DURING A PTBD PROCEDURE. AFTER DEVICE INSERTION, IT WAS DISCOVERED THAT THE CATHETER WAS LEAKING FROM THE HUB. THE DEFECTIVE CATHETER WAS REMOVED AND SUCCESSFULLY EXCHANGED WITH A LIKE DEVICE.
Patient problems: No Code Available
MAUDE report 7822292 ↗MalfunctionJul 9, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS FOUND TO BE LEAKING AT THE HUB SEAM DURING AN ABSCESS DRAIN T THE PATIENTS BILE DUCT. THE DEVICE WAS REMOVED AND A 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 Known Impact Or Consequence To Patient
MAUDE report 7671824 ↗InjuryJun 13, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS LEAKING AT THE HUB CONNECTION ABOUT TEN DAYS AFTER A ROUTINE NEPHROSTOMY EXCHANGE. THE PATIENT RETURNED TO THE FACILITY FOR AN EXCHANGE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 7598267 ↗InjuryMar 15, 2018Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE HUB OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER PREVIOUSLY PLACED AS A CHEST TUBE IN THE RIGHT PLEURAL SPACE ON (B)(6) 2018, SEPARATED FROM THE CATHETER PORTION OF THE DEVICE. AS A RESULT, THE CATHETER HAD TO BE REPLACED. THE PATIENT WAS CURRENTLY INTUBATED IN THE INTENSIVE CARE UNIT (ICU), AND THE CAUSE OF THE DISCONNECTION OF THE DEVICE WAS NOT KNOWN. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Code Available
MAUDE report 7344008 ↗InjuryMar 15, 2018Material Separation; Material Separation
THE CUSTOMER REPORTED THAT, DURING THE MIDDLE OF THE NIGHT ON (B)(6) 2018, WHEN THE PATIENT WAS WALKING BACK FROM THE BATHROOM TO THEIR BED, THE HUB OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WHICH WAS PLACED ON (B)(6) 2018 AS A CHEST TUBE IN THE RIGHT PLEURAL SPACE, SEPARATED FROM THE CATHETER PORTION OF THE DEVICE. AS A RESULT, THE CATHETER HAD TO BE REPLACED IN ANOTHER PROCEDURE. NO FURTHER DEVICE ISSUES WERE REPORTED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Code Available
MAUDE report 7343986 ↗MalfunctionFeb 9, 2018Air Leak; Air Leak
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHILE USING THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER TO DRAIN THE PATIENT DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE, IT WAS DISCOVERED THAT THERE WAS NO AIR PRESSURE IN THE CATHETER, AND AIR WAS LEAKING FROM THE HUB PORTION OF THE DEVICE. ANOTHER DEVICE WAS EMPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE HEALTHY. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7261508 ↗MalfunctionNov 13, 2017Detachment Of Device Component; Component Falling
IT WAS REPORTED THAT DURING UNKNOWN PROCEDURES, THE HUBS FELL OFF. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7025032 ↗MalfunctionNov 13, 2017Air Leak
IT WAS REPORTED THAT WHEN THE USER WAS ASPIRATING THROUGH THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER ON MULTIPLE PASSES IT WAS NOTED THAT AIR WAS BEING PULLED BACK. WHEN THE USER OBSERVED IT WAS THE DRAIN, IT WAS REPLACED WITH ANOTHER DEVICE. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7024929 ↗MalfunctionNov 10, 2017Bent; Material Frayed; Sticking
IT WAS REPORTED THAT ANOTHER MANUFACTURER'S WIRE BECAME STUCK IN THE DRAINAGE CATHETER AND WAS BENT AND FRAYED UPON REMOVAL, AND THAT A PIECE OF PLASTIC BROKE FROM THE DEVICE. HOWEVER, THE CATHETER WAS FOUND TO BE INTACT AND UNDAMAGED. ANOTHER SET WAS USED TO CONTINUE THE PROCEDURE, NO PIECES WERE LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7021802 ↗
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- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page