Cook G09497Recalls & reported problems
Cook Incorporated · Biliary Drainage Catheter Ultrathane · Class U · Implant
Quick summary
This Cook Ultrathane biliary drainage catheter is a thin tube placed to drain bile from the bile ducts. Of its 127 reports, 112 are malfunctions and 15 are injuries, with no deaths; many describe the inner stiffening tube being hard to remove or breaking during removal, and some describe leaks or separated parts. 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
- 129
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00827002094970), received between Jul 20, 2016 and Sep 29, 2026 — classified as 15 injuries, 114 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (65 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 Remove65
- Leak/Splash17
- Material Separation14
- Break7
- Detachment of Device or Device Component7
- Difficult to Advance6
- Failure to Advance6
- Fluid/Blood Leak4
Patient problems
- No Known Impact Or Consequence To Patient54
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient12
- No Code Available10
- No Patient Involvement5
- Pain3
- Foreign Body In Patient2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935450 ↗MalfunctionSep 24, 2026Difficult to Remove
It was reported that the stiffening cannula was difficult to remove from an Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter.The drainage catheter itself remained in place in the patient. However, problems occurred during the removal of the "inner cannula".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 50883108 ↗MalfunctionApr 6, 2026Difficult to Remove
IT WAS REPORTED THAT THE STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. THE DEVICE WAS REQUIRED FOR BILIARY DRAINAGE DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY AND DRAINAGE (PTCD) PROCEDURE. THE STIFFENING CANNULA BECAME LODGED AT THE PIGTAIL TIP OF THE CATHETER, MAKING IT DIFFICULT TO REMOVE. THIS LED TO PAIN, BILIARY TRACT INJURY, AND MINOR BLEEDING FOR THE PATIENT. THE CATHETER AND STIFFENING CANNULA WERE REMOVED TOGETHER, AND A NEW LIKE DEVICE 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. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 24790749 ↗MalfunctionMay 15, 2025Break; Difficult to Remove; Break; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Pain
MAUDE report 22027812 ↗InjuryFeb 4, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 21305004 ↗MalfunctionJan 3, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS FOUND TO BE OCCLUDED DURING A PERCUTANEOUS BILIARY DRAINAGE (PTCD) PROCEDURE ON A 68-YEAR-OLD FEMALE PATIENT. A PERCUTANEOUS INTRODUCER WAS USED TO PUNCTURE THE BILE DUCT, AND AFTER CONFIRMATION OF NO ERROR, THE BILIARY DRAINAGE CATHETER WAS INTRODUCED ALONG THE WIRE GUIDE. THE CATHETER WAS ADVANCED TO THE TARGET POSITION, AND THE STIFFENER WAS WITHDRAWN. WHEN PREPARING TO CONFIRM THE POSITION OF THE CATHETER WITH IMAGING, IT WAS FOUND THAT CONTRAST WAS UNABLE TO BE INJECTED THROUGH THE CATHETER. SEVERAL ATTEMPTS TO REPOSITION AND SUCTION THE CATHETER WERE MADE; HOWEVER, THE CONTRAST AGENT WAS UNABLE TO BE PROPERLY INJECTED. THE DRAINAGE CATHETER WAS THEN REMOVED FROM THE PATIENT, AND A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 21069738 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CATHETER WAS RETURNED TO COOK WITH THE METAL STIFFENING CANNULA INSIDE. DURING PRELIMINARY DEVICE FAILURE ANALYSIS, THE METAL CANNULA BROKE DURING ATTEMPTED REMOVAL FROM THE CATHETER. ADDITIONAL INFORMATION REGARDING THIS OBSERVATION HAS BEEN REQUESTED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799343 ↗MalfunctionOct 23, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENING CANNULA OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS DIFFICULT TO REMOVE DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. AS PER THE PHYSICIAN, CATHETER WAS SUCCESSFULLY PLACED IN THE DUODENUM. HOWEVER, WHILE REMOVING THE STIFFENING CANNULA, IT BECAME STUCK TO THE CATHETER AND COULD NOT BE REMOVED. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED 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 20517223 ↗MalfunctionSep 5, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FLEXIBLE STIFFENER FROM AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS DIFFICULT TO WITHDRAW AND SEPARATED DURING PERCUTANEOUS HEPATIC BILIARY DRAINAGE IN A 42-YEAR-OLD FEMALE PATIENT WITH BILE DUCT STONES. AN 8.5FR ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS INTRODUCED ALONG THE M-EXCHANGE GUIDEWIRE INTO THE TARGET SITE WITHOUT INCIDENT. RESISTANCE WAS THEN ENCOUNTERED DURING AN ATTEMPTED WITHDRAWAL OF THE GUIDE WIRE AND FLEXIBLE STIFFENER. AS A RESULT, THE FLEXIBLE STIFFENER SEPARATED AS THE FORCE OF REMOVAL WAS INCREASED. THE CATHETER WAS CUT AND THE FLEXIBLE STIFFENER WAS ABLE TO BE REMOVED WITH CURVED FORCEPS. THE GUIDE WIRE WAS RE-INTRODUCED INTO THE CATHETER AND THEN THE REMAINING DEVICE WAS REMOVED AS A UNIT FROM THE PATIENT. A NEW LIKE-DEVICE WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED 15 MINUTES DUE TO THE FAILURE. 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 20148084 ↗MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FLEXIBLE STIFFENER FROM AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS DEFECTIVE, SO ANOTHER DEVICE WAS OPENED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. UPON RECEIPT OF THE COMPLAINT DEVICE, IT WAS DISCOVERED THE FLEXIBLE STIFFENER WAS ELONGATED, AND THE HUB WAS SEPARATED, THUS PROMPTING THIS REPORT. THE HUB WAS NOT RETURNED.
Patient problems: Insufficient Information
MAUDE report 19608207 ↗InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS PROVIDED. IT WAS CLARIFIED THAT A NEW CATHETER WAS NOT USED FOR THE REPLACEMENT PROCEDURE. THE DOCTOR ATTEMPTED TO REPLACE THE ORIGINAL CATHETER BUT WAS UNSUCCESSFUL. THE CATHETER WAS THEN COMPLETELY REMOVED AND DISCARDED BY THE HOSPITAL. AS REPORTED, THE PATIENT IS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19455007 ↗MalfunctionMay 16, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE METAL STIFFENER WAS DIFFICULT TO REMOVE FROM AN 'ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER' WHEN TESTED PRIOR TO USE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW 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 19335935 ↗MalfunctionMay 9, 2024Difficult to Remove; Difficult to Remove
ADDITIONAL INFORMATION WAS PROVIDED ON 08MAY2024. THE METAL STIFFENER WAS THE PART OF THE DEVICE THAT WAS UNABLE TO BE REMOVED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280112 ↗MalfunctionApr 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER LEAKED WHEN BEING PLACED IN THE ABDOMEN DURING A BILIARY DRAINAGE PROCEDURE. DURING THE PROCEDURE WHEN THE PHYSICIAN WAS PERFORMING A CHOLANGIOGRAPHY TO VERIFY THE POSITION OF THE CATHETER, A LEAK WAS OBSERVED AT THE PROXIMAL PORTION OF THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19061098 ↗MalfunctionJan 8, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 18470255 ↗MalfunctionNov 9, 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 18103511 ↗MalfunctionOct 25, 2023Leak/Splash; Leak/Splash
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 18007500 ↗MalfunctionOct 9, 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 17901569 ↗MalfunctionSep 28, 2023Difficult to Remove; Material Separation; Detachment of Device or Device Component; Difficult to Remove; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THE BLUE FLEXIBLE STIFFENER OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER SEPARATED DURING AN UNKNOWN PROCEDURE FOR A MALE PATIENT WHO NEEDED BILIARY DRAINAGE DUE TO NEOPLASIA. THE PUNCTURE AND TARGET PLACEMENT WAS CARRIED OUT IN THE RIGHT FLANK BY THE PHYSICIAN WITHOUT COMPLICATIONS. DURING THE PROCEDURE, THE CATHETER WOULD NOT ADVANCE OVER THE HYDROPHILIC OR HIGH SUPPORT WIRE GUIDES DESPITE VARIOUS MANEUVERS DONE BY THE END USER. IN THE END, THE BLUE FLEXIBLE STIFFENER BECAME STUCK IN THE CATHETER AND THE "CUBE" SEPARATED AS ATTEMPTS WERE MADE TO REMOVE IT. THE DEVICE WAS REMOVED AND REPLACED BY ANOTHER MANUFACTURER'S DRAIN. 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 17839690 ↗MalfunctionAug 10, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 17499932 ↗MalfunctionAug 3, 2023Difficult 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17455192 ↗MalfunctionJul 25, 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 17390358 ↗InjuryJul 20, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
THE 48-YEAR-OLD FEMALE PATIENT FIRST UNDERWENT A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) ON (B)(6) 2023. THE PTC WAS INDICATED AS PREVIOUS INTRA AND COMMON DILATION AND RIGHT HEPATIC DUCT STENT PLACEMENT HAD BEEN COMPLETED PREVIOUSLY. HOWEVER, THE LEFT HEPATIC DUCT WAS UNABLE TO BE STENTED DUE TO ACCESS, REQUIRING A PTC TO ASSIST WITH A PASSAGE TO INSERT A PLASTIC STENT VIA ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). DURING THE ERCP, A COOK NEFF PERCUTANEOUS ACCESS SET WAS USED TO ACCESS THE RIGHT DUCT. ONCE ACCESS WAS ACHIEVED A COMPETITOR'S WIRE GUIDE AND 5 FRENCH 65 CM CATHETER WERE USED AND ADVANCED INTO THE COMMON BILE DUCT AND TO CROSS THE STRICTURE. ONCE THE STRICTURE WAS CROSSED, THE WIRE GUIDE WAS REMOVED, AND AN AMPLATZ .035 X 180 CM WIRE GUIDE WAS PLACED. AFTER FLUSHING THE COOK ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER IT WAS ADVANCED OVER THE WIRE GUIDE, INTO THE LEFT COMMON BILE DUCT, AND INTO THE DUODENUM. THE COOK ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS INTENDED TO SERVE AN INTERNAL AND EXTERNAL DRAINAGE SYSTEM. AFTER THE POSITIONING OF THE COOK ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS COM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17362421 ↗MalfunctionJun 28, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221202 ↗MalfunctionJun 12, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108492 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 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
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.