Cook G09498Recalls & reported problems
Cook Incorporated · Biliary Drainage Catheter Ultrathane · Class U · Implant
Quick summary
This Cook G09498 Ultrathane biliary drainage catheter is a soft tube placed through the skin to drain bile or urine from the body. The 27 reports mostly describe fluid leaking from the catheter or its hub, catheters that were hard to pull out, and packaging that arrived contaminated or unsealed. Three reports involve injuries and 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
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00827002094987), received between Oct 3, 2016 and Mar 2, 2026 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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
- Leak/Splash6
- Difficult to Remove5
- Device Contaminated During Manufacture or Shipping4
- Fluid/Blood Leak4
- Unsealed Device Packaging2
- Break1
- Component Falling1
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient3
- No Code Available2
- No Patient Involvement2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER LEAKED AT THE HUB. THE DEVICE WAS REQUIRED FOR A BILIARY CATHETER REPLACEMENT PROCEDURE. AFTER ASEPTIC AND ANTISEPTIC PREPARATION AND PLACEMENT OF STERILE DRAPES, A HYDROPHILIC GUIDEWIRE WAS ADVANCED OVER THE PREVIOUSLY IMPLANTED BILIARY CATHETER, AND THE CATHETER WAS REMOVED. THE GUIDEWIRE IS USED TO MAINTAIN ACCESS, AND A NEW 10.2 FR BILIARY DRAINAGE CATHETER WAS ADVANCED OVER THE WIRE AND WAS SECURED WITH THE MAC-LOC SYSTEM. WHEN THE DRAINAGE BAG WAS CONNECTED, PERSISTENT LEAKAGE OF BILE WAS IDENTIFIED AT THE PROXIMAL LOCKING SYSTEM. THIS CATHETER WAS THEN REMOVED, AND A NEW CATHETER WAS INSERTED 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 24489983 ↗InjuryFeb 10, 2026Fluid/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 24306120 ↗MalfunctionNov 24, 2025Device 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 23638667 ↗MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER LEAKED DURING A LIVER DRAINAGE PROCEDURE FOR A 79-YEAR-OLD FEMALE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515591 ↗MalfunctionMay 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN 'ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER' LEAKED AT THE COLLECTION BAG INSERTION SITE. NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19291361 ↗MalfunctionNov 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 18143097 ↗MalfunctionJun 30, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem
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 17238198 ↗MalfunctionFeb 1, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE FROM AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. DURING A NEPHROSTOMY CATHETER CHECK AND EXCHANGE OF A RIGHT TRANSPLANT KIDNEY NEPHROURETERECTOMY TUBE IN AN UNKNOWN PATIENT, THE FLEXIBLE STIFFENER BECAME STUCK IN THE DRAINAGE CATHETER UPON WITHDRAWAL. THE PHYSICIAN REMOVED THE CATHETER AND STIFFENER TOGETHER AND REPLACED IT WITH ANOTHER LIKE 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 16278059 ↗MalfunctionSep 8, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER LEAKED BETWEEN THE MAC-LOC HUB AND CATHETER CAP. A NEW DEVICE WAS OBTAINED 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 15380667 ↗MalfunctionDec 13, 2021Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT AN UNUSED ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS FOUND TO BE DAMAGED AT THE DISTRIBUTOR. PHOTOS PROVIDED SHOW THE PACKAGING DID NOT HAVE A SEAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12987761 ↗InjurySep 16, 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 12482814 ↗MalfunctionJun 22, 2021Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent
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 12041794 ↗MalfunctionMar 5, 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 11421148 ↗MalfunctionOct 14, 2020Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE DILATOR WAS DIFFICULT TO REMOVE AND THE CATHETER KINKED AND ACCORDIONED. A SECOND DEVICE WAS USED OF THE SAME LOT AND THE SAME FAILURE OCCURRED. ANOTHER 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.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10680924 ↗MalfunctionApr 27, 2020Material Separation; 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 10001375 ↗MalfunctionApr 14, 2020Device 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 Known Impact Or Consequence To Patient
MAUDE report 9958250 ↗MalfunctionJan 28, 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 9636832 ↗InjuryJun 3, 2019Fracture; Fracture
IT WAS REPORTED A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED IN A (B)(6)-YEAR-OLD FEMALE DURING A GRANULAR COLESISTOMA PROCEDURE. AS REPORTED: "THE DRAIN WAS SUCCESSFULLY PLACED ON (B)(6) 2019 (RIGHT TUBE AND A LEFT TUBE). PATIENT BILIRUBIN WAS ELEVATED SO BROUGHT THE PATIENT BACK ON (B)(6) 2019 TO POTENTIALLY UPSIZE THE TUBES. WIRE PLACED IN LEFT SIDE TUBE FIRST, THEN IN RIGHT SIDE TUBE. INITIAL FRACTURE NOT NOTICED UPON WIRE PLACEMENT. PHYSICIAN NOTICED COPE LOOP ON THE DRAIN DID NOT RELEASE AND OBSERVED THE FRACTURE IN THE CATHETER. THE PORTION OF THE CATHETER SLID DOWN INTO DUODENUM." THE REPORT STATES THE PHYSICIAN USED SNARE DEVICE AND WAS ABLE TO RETRIEVE THE SEGMENT SUCCESSFULLY. THE REPORT FURTHER STATES, ¿CATHETER BROKE A SECOND TIME, AND PHYSICIAN HAD TO PUSH THE CATHETER INTO THE DUODENUM TO RETRIEVE IT AND FOUND IT WAS FOLDED ON ITSELF UPON RETRIEVAL. NO DRAINS WERE LEFT AFTER THE PROCEDURE. PATIENT WENT FOR ADDITIONAL SURGERY AND HAD SOME OF THE CARCINOMA RESECTED, BUT NO ISSUES WERE OBSERVED FROM THE PRIOR PROCEDURE." NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Code Available
MAUDE report 8663656 ↗MalfunctionDec 27, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION HAS BEEN ADDED TO THE EVENT DESCRIPTION SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.
Patient problems: No Patient Involvement
MAUDE report 8199920 ↗MalfunctionSep 14, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED INTO THE BILIARY TRACT OF A PATIENT DURING A DRAINAGE PROCEDURE. NOT LONG AFTER DEVICE PLACEMENT, IT WAS DISCOVERED THAT AIR WAS LEAKING FROM THE HUB. THE PHYSICIAN OPENED ANOTHER LIKE DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 7877536 ↗MalfunctionApr 30, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) IN THE CHEST, THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WOULD NOT SEPARATE FROM THE CANNULA. THE DEVICE WAS REMOVED. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS NOT BEEN PROVIDED. 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 7472947 ↗MalfunctionNov 9, 2017Detachment Of Device Component
THE COMPLAINANT REPORTED THAT THE HUB DETACHED FROM BILIARY DRAIN. IT IS UNKNOWN HOW LONG THE COMPLAINT DEVICE WAS IN PLACE, BUT THE DEVICE WAS EXCHANGED. THERE WERE NO REPORTS OF ANY SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY AND THE INITIAL REPORTER NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7015663 ↗MalfunctionNov 9, 2017Leak/Splash
IT WAS REPORTED THAT DURING THE PROCEDURE BILE WAS NOTED TO BE LEAKING FROM THE HUB, ALLEGEDLY DUE TO A BAD SEAL. A NEW BILIARY TUBE WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 7014660 ↗MalfunctionNov 9, 2017Component Falling
DURING A BILIARY TUBE PLACEMENT PROCEDURE, THE MAC-LOC HUB FELL OFF. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER TUBE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF ANY SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY OR ANY ADDITIONAL PROCEDURES (INTERVENTION) AS A RESULT OF THIS PRODUCT PROBLEM. ADDITIONALLY, THE INITIAL REPORTER NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7013744 ↗MalfunctionNov 7, 2017Leak/Splash
AFTER THE DRAIN WAS PLACED, IT BEGAN TO LEAK AT THE JUNCTION BETWEEN THE CATHETER AND THE HUB. IT WAS NEEDED TO BE SCREWED BACK TOGETHER. A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS BODY WAS IT WAS INTENDED AS THE INITIAL DRAINAGE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient
MAUDE report 7007757 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.