Cook G06083Recalls & reported problems
Cook Incorporated · Biliary Drainage Catheter Ultrathane · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002060838), received between Dec 21, 2018 and Dec 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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.
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED AN ULTRATHANE COOK-COPE TYPE LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S BILE DUCT DURING A PERCUTANEOUS TRANS-HEPATIC BILIARY DRAINAGE PROCEDURE. AFTER THE PHYSICIAN INSERTED THE CATHETER, THE BLUE PLASTIC STIFFENER WAS UNABLE TO BE REMOVED. IT WAS ALSO REPORTED THAT THE STIFFENER ACCORDIONED AFTER SOME FORCE WAS USED. AS A RESULT, THE PHYSICIAN REMOVED THE CATHETER ALONG WITH THE STIFFENER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH USING ANOTHER CATHETER WITH STIFFENER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONALLY, PER THE CUSTOMER, THE PATIENT IS "FINE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8189044 ↗
Other CATHETER, BILIARY, SURGICAL devices
- FOGARTY 410236FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410405FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410235FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- Fusion Quattro G48225Cook Incorporated · CATHETER, BILIARY, SURGICAL22 reports
- Fusion G31537Cook Incorporated · CATHETER, BILIARY, SURGICAL15 reports
- Fusion Quattro G31922Cook Incorporated · CATHETER, BILIARY, SURGICAL5 reports
- Tri-Ex G26856Cook Incorporated · CATHETER, BILIARY, SURGICAL4 reports
- Fusion Quattro G31921Cook Incorporated · CATHETER, BILIARY, SURGICAL4 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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