Cook G09765Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Multipurpose Drainage Catheter is a soft, thin tube used to drain fluid from the body. The 31 reports mostly describe the catheter being hard to remove, and material separating or breaking apart — in one report, two drains broke inside a patient during placement, though all pieces were retrieved. 3 reports describe injuries. No deaths were reported, and 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002097650), received between Nov 1, 2017 and Jul 27, 2026 — classified as 3 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (22 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
- Difficult to Remove22
- Material Separation15
- Difficult to Advance2
- Leak/Splash2
- Crack1
- Detachment of Device or Device Component1
- Failure to Advance1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient13
- No Clinical Signs, Symptoms or Conditions10
- Discomfort3
- Insufficient Information3
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
- No Code Available1
- Pain1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50039758 ↗MalfunctionMar 10, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Discomfort
MAUDE report 21563915 ↗MalfunctionJan 3, 2025Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 21072005 ↗MalfunctionMay 10, 2024Difficult to Remove; Material Separation; Detachment of Device or Device Component; Difficult to Remove; Material Separation; 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 19287813 ↗MalfunctionJan 10, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18486002 ↗MalfunctionSep 6, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17690804 ↗InjuryApr 25, 2023Crack; 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811546 ↗InjuryJun 27, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED A PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THEY STATED THAT DURING PLACEMENT "TWO DRAINS BROKE IN THE PATIENT", BUT THEY WERE ABLE TO SUCCESSFULLY RETRIEVE "ALL THE PIECES OUT OF THE PATIENT." TWO USED DRAINAGE CATHETERS ALONG WITH TWO BLUE FLEXIBLE STIFFENERS WERE RETURNED TO COOK ON (B)(6) 2022. THE FIRST DRAINAGE CATHETER AND FLEXIBLE STIFFENER WERE INTACT BUT THE STIFFENER WAS NOTED TO HAVE MULTIPLE KINKS PRESENT, LIKELY FROM DIFFICULTY REMOVING THE FLEXIBLE STIFFENER. THE SECOND DRAINAGE CATHETER AND FLEXIBLE STIFFENER WERE RETURNED SEPARATED. THE SHAFT OF THE PROXIMAL END OF THE CATHETER WAS SEPARATED WITH THE HUB MISSING. THE FLEXIBLE STIFFENER WAS SEPARATED IN 3 PIECES AND ELONGATED WITH THE HUB MISSING. THERE WAS NO RETRIEVAL REQUIRED FOR THE FIRST DEVICE. FOR THE SECOND DEVICE, ALL DEVICE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE, BUT IT IS CURRENTLY UNKNOWN IF THIS HAS OCCURRED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES THE DRAINAGE CATHETER AND FLEXIBLE STIFFEN
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14835593 ↗MalfunctionJun 27, 2022Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED A PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THEY STATED THAT DURING PLACEMENT "TWO DRAINS BROKE IN THE PATIENT", BUT THEY WERE ABLE TO SUCCESSFULLY RETRIEVE "ALL THE PIECES OUT OF THE PATIENT." TWO USED DRAINAGE CATHETERS ALONG WITH TWO BLUE FLEXIBLE STIFFENERS WERE RETURNED TO COOK ON (B)(6) 2022. THE FIRST DRAINAGE CATHETER AND FLEXIBLE STIFFENER WERE INTACT BUT THE STIFFENER WAS NOTED TO HAVE MULTIPLE KINKS PRESENT, LIKELY FROM DIFFICULTY REMOVING THE FLEXIBLE STIFFENER. THE SECOND DRAINAGE CATHETER AND FLEXIBLE STIFFENER WERE RETURNED SEPARATED. THE SHAFT OF THE PROXIMAL END OF THE CATHETER WAS SEPARATED WITH THE HUB MISSING. THE FLEXIBLE STIFFENER WAS SEPARATED IN 3 PIECES AND ELONGATED WITH THE HUB MISSING. THERE WAS NO RETRIEVAL REQUIRED FOR THE FIRST DEVICE. FOR THE SECOND DEVICE, ALL DEVICE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE, BUT IT IS CURRENTLY UNKNOWN IF THIS HAS OCCURRED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES THE FIRST FLEXIBLE STIFFENER THAT WAS RETU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14835590 ↗MalfunctionApr 5, 2021Unsealed Device Packaging; Unsealed Device Packaging
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 11613279 ↗MalfunctionMar 17, 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 11505766 ↗MalfunctionMar 17, 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 11505442 ↗InjuryFeb 16, 2021Difficult to Remove; Material Separation
ADDITIONAL INFORMATION PROVIDED 03MAR2021 STATED THE DEVICE WAS BEING USED FOR A NEPHROSTOMY TUBE CHANGE. IT WAS CLARIFIED THAT IT WAS THE FLEXIBLE STIFFENER THAT BROKE OFF INSIDE THE PATIENT AND GUIDEWIRES WERE REQUIRED TO RETRIEVE THE BROKEN STIFFENER FROM THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Code Available
MAUDE report 11335977 ↗MalfunctionDec 5, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A STENT EXCHANGE PROCEDURE. ONCE THE STENT WAS CORRECTLY POSITIONED, THE BLUE FLEXIBLE STIFFENER WAS NOT EASILY REMOVABLE. A DEVICE 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10952070 ↗MalfunctionOct 28, 2020Difficult to Remove; Material Separation; Difficult to Remove; 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 10750617 ↗MalfunctionOct 28, 2020Difficult to Remove; Difficult to Remove
THIS COMPLAINT IS BEING CANCELED. ADDITIONAL INFORMATION WAS RECEIVED ON 29OCT2020 THAT INDICATES THIS EVENT WAS REPORTED IN ERROR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10750587 ↗MalfunctionOct 28, 2020Difficult to Remove; Material Separation; Difficult to Remove; 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 10750462 ↗MalfunctionJul 29, 2020Leak/Splash; Material Separation; Leak/Splash; 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 10340643 ↗MalfunctionJun 25, 2020Leak/Splash; Leak/Splash
UPON EVALUATION OF RETURNED DEVICES ON 14JUL2020, IT WAS DISCOVERED THAT ONE OF THE CATHETERS WAS SEPARATED AT THE HUB. THE DEVICE THAT ONLY LEAKED AT THE HUB IS REPORTED UNDER MEDWATCH REPORT #: 1820334-2020-01193 (THIS REPORT). THE DEVICE THAT SEPARATED AT THE HUB AND LEAKED IS REPORTED UNDER THE MEDWATCH REPORT #: 1820334-2020-01380.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10196758 ↗MalfunctionApr 14, 2020Failure to Advance; Failure to Advance
MalfunctionApr 14, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN NUMBER OF ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS "BROKE" DURING NEPHROSTOMY TUBE CHANGES. ADDITIONAL INFORMATION REGARDING THE EVENT, QUANTITY OF DEVICES, FAILURE MODE, AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9958046 ↗MalfunctionMar 6, 2020Difficult to Remove; Material Separation; Difficult to Remove; 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 9801158 ↗MalfunctionFeb 18, 2020Difficult 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 Consequences Or Impact To Patient
MAUDE report 9722614 ↗MalfunctionFeb 18, 2020Difficult 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 Known Impact Or Consequence To Patient
MAUDE report 9722548 ↗MalfunctionFeb 12, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Pain
MAUDE report 9700511 ↗
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
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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