Cook G09205Recalls & reported problems
Cook Incorporated · Biliary Drainage Catheter Ultrathane · Class U · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002092051), received between Aug 9, 2017 and Nov 15, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Split” (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
- Adverse Event Without Identified Device or Use Problem1
- Split1
Patient problems
- Foreign Body In Patient1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2017Split
IT WAS REPORTED THAT BEFORE INSERTION THE DOCTOR NOTED THAT THE CATHETER HAS A SPLIT END.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7034717 ↗InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORT RECEIVED VIA MEDSUN REPORT (B)(4) : "WHILE REMOVING A NEPHROSTOMY TUBE DURING A TRANSPLANTED KIDNEY NEPHRECTOMY AFTER REJECTION LAST FALL, THE NEPHROSTOMY TUBE WAS CUT AS PART OF THE PROCEDURE AND THE MAIN PART OF THE TUBING WAS REMOVED ON THE KIDNEY SIDE. A 4CM PIECE OF THE TUBING THAT WAS IN THE BLADDER WAS NOT REMOVED AND THUS RETAINED IN THE PATIENT. THIS WAS DISCOVERED DURING RECENT HOSPITALIZATION ON CT SCAN AND IT WAS REMOVED YESTERDAY. " ORIGINAL INTENDED PROCEDURE: LEFT-SIDED TRANSPLANT NEPHRECTOMY WITH NEPHROSTOMY TUBE REMOVAL." INSTRUCTIONS FOR USE THAT ACCOMPANY EACH DEVICE PROVIDE INSTRUCTIONS FOR THE REMOVAL AND EXCHANGE OF THE CATHETERS.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 6777555 ↗
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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