Ring G06909Recalls & reported problems
Cook Incorporated · Ring Biliary Duct Drainage Catheter Ultrathane · Class U · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002069091), received between Jul 1, 2025 and Apr 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Difficult to Remove
IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM THE ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE FOR AN UNKNOWN PATIENT. THE USER NOTED THAT THE PLASTIC STIFFENING CANNULA BECAME JAMMED INSIDE THE CATHETER AFTER POSITIONING, RESULTING IN THE INABILITY TO FORM THE PIGTAIL CURL IN THE PATIENT. THE DRAINAGE CATHETER AND FLEXIBLE STIFFENING CANNULA WERE THEN REMOVED FROM THE PATIENT AS A UNIT AND A NEW LIKE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A PHOTO OF THE DEVICE PROVIDED BY THE CUSTOMER CONFIRMS THAT THE STIFFENING CANNULA WAS LODGED IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782266 ↗MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER SEPARATED AT THE HUB DURING REMOVAL FROM THE PATIENT FOLLOWING ITS PLACEMENT FOR A DRAINAGE PROCEDURE, RESULTING IN A PROCEDURAL DELAY. HOWEVER, THE ENTIRE DEVICE WAS SUCCESSFULLY RETRIEVED WITHOUT CAUSING ANY HARM TO THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371946 ↗
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- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.