Dawson Mueller G10436Recalls & 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
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002104365), received between Jun 23, 2017 and Jan 22, 2024 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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
- Detachment of Device or Device Component4
- Device Contaminated During Manufacture or Shipping2
- Detachment Of Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Insufficient Information1
- Pneumothorax1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 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 INCIDENT WAS DISCOVERED DURING GENERAL INSPECTION, PRIOR TO USING THE DEVICE. 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 18553774 ↗MalfunctionJan 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE PRIOR TO USE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE HUB OF THE CATHETER SEPARATED FROM THE CATHETER SHAFT. ANOTHER PRODUCT WAS OPENED TO COMPLETE THE BILIARY DRAINAGE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13286041 ↗MalfunctionNov 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IN ADDITIONAL INFORMATION RECEIVED ON 03DEC2021, IT WAS REPORTED THAT THE ADMITTED PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE FAILURE WAS NOTICED DURING THE PROCEDURE, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12736885 ↗MalfunctionFeb 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS INSPECTED AT A DISTRIBUTOR. A HAIR-LIKE FIBER WAS NOTED INSIDE THE PRIMARY PACKAGING OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 11272930 ↗MalfunctionOct 5, 2020Difficult to Remove; Difficult to Remove
InjuryJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionNov 15, 2017Detachment Of Device Component
IT WAS REPORTED THAT THERE WAS A SEPARATION FROM THE CATHETER AND THE CATHETER HUB PART. A NEW PRODUCT USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7033817 ↗MalfunctionJun 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
INTERNATIONAL CUSTOMER REPORTED THAT THE "VALVE" WAS NOT ATTACHED TO THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. PHOTOGRAPH PROVIDED BY THE CUSTOMER SHOWS THE MAC-LOC SEPARATED FROM THE CATHETER. THE EVENT WAS NOTED UPON OPENING THE PACKAGE BEFORE PATIENT CONTACT. THERE ARE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 6662626 ↗
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
- 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.
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