Dawson Mueller G51594Recalls & 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002515949), received between Nov 10, 2017 and Nov 5, 2019 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Detachment Of Device Component2
- Difficult to Remove2
- Fluid/Blood Leak2
- Leak/Splash2
- Activation, Positioning or Separation Problem1
- Difficult to Insert1
- Occlusion Within Device1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 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 Patient Involvement
MAUDE report 9281527 ↗MalfunctionOct 8, 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 9167041 ↗MalfunctionAug 29, 2019Fluid/Blood Leak; Fluid/Blood Leak
DURING MANUFACTURER BENCH TESTING OF RETURNED DEVICES, SIX UNUSED ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS WERE FOUND TO LEAK. THESE CATHETERS AND NINE OTHER UNUSED CATHETERS FROM THE SAME LOT WERE ORIGINALLY RETURNED AGAINST MEDWATCH REPORT #1820334-2019-01891 AS UNUSED DEVICES FOR INVESTIGATION. THESE DEVICES DID NOT MAKE PATIENT CONTACT. THEY WERE RETURNED UNUSED IN THE ORIGINAL SEALED PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 8944026 ↗MalfunctionAug 1, 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 8851428 ↗MalfunctionJun 5, 2019Difficult to Insert; Difficult to Remove; Difficult to Insert; 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 Known Impact Or Consequence To Patient
MAUDE report 8670401 ↗MalfunctionApr 2, 2018Difficult to Remove; Difficult to Remove
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7390410 ↗MalfunctionFeb 21, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE CUSTOMER REPORTED THAT, DURING PLACEMENT OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER IN THE PATIENT'S ABDOMEN AS PART OF A SCLEROTHERAPY PROCEDURE, THE TROCAR NEEDLE WASN¿T PROTRUDING OUT OF THE END AS EXPECTED. A DIRECT STICK WAS NOT POSSIBLE, AND THE OPERATOR HAD TO BACK THE PRODUCT OUT, WHICH RESULTED IN AN INABILITY TO REMOVE THE NEEDLE FROM THE CATHETER ONCE IT WAS IN THE PATIENT. THE DEVICE HAD TO BE REMOVED, AND A RE-STICKING OF THE PATIENT WAS NECESSARY. THE DEVICE WAS REPORTEDLY ONLY IN PLACE FOR A PERIOD OF MINUTES, AND THE CUSTOMER REPORTED THAT NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE ISSUE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7287002 ↗MalfunctionDec 18, 2017Occlusion Within Device; Occlusion Within Device
THE INTERNATIONAL CUSTOMER REPORTED THAT THE RADIOLOGIST OPERATING THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER COULD NOT PULL THE STIFFENING CANNULA OUT OF THE CATHETER, EVEN AFTER PRIMING THE DRAIN AND ACTIVATING THE HYDROPHILIC COATING. THE CATHETER WAS ACCORDIONING AS A RESULT, AND ULTIMATELY THE WHOLE CATHETER ASSEMBLY HAD TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS AN ASCITIC TAP. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7126315 ↗MalfunctionNov 10, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT THE HUB BROKE OFF FROM THE CATHETER. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7017711 ↗MalfunctionNov 10, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT THE HUB BROKE OFF FROM THE CATHETER. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7017552 ↗
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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