Leung G21523Recalls & reported problems
Cook Ireland Ltd · Leung, Nasal Biliary Drainage Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002215238), received between Sep 9, 2025 and Sep 9, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Break; Break
NASAL BILIARY DRAINAGE TUBE WAS PLACED ONE DAY BEFORE THE PATIENT'S OT SESSION. AFTER OT, THE SURGEON REMOVES THE NASAL BILIARY TUBE AND FOUND OUT THE TUBE WAS DAMAGED. SURGEON WOULD LIKE TO SEND BACK THE DAMAGED TUBE TO US FOR INVESTIGATION ON WHETHER THE TUBE'S MATERIAL HAVE ANY DEFECTED. PIECES OF THE CATHETER BROKE INSIDE THE PATIENTS BODY AND REQUIRED REMOVAL. 1. WAS THE DEVICE FLUSHED BEFORE USE? YES. 2. WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, CONTRAST, ETC.)? NORMAL SALINE. 3. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? SEARCH FOR ANY SIMILAR PRODUCT TO SUBSTITUTE IN THE MARKET. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? BOSTON SCIENTIFIC HYDRA JAGWIRE 0.035IN X 450CM. 5. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. BILIARY SYSTEM. 6. WAS THE PATIENT¿S ANATOMY TORTUOUS? NO. 7. WHAT WAS THE PATIENT¿S PRE-EXISTING CONDITION(S)? 8. WAS THE DEVICE STRAIGHTENED WITH THE PIGTAIL STRAIGHTENER (IF APPLICABLE)? N/A. 9. WAS THE ISSUE OBSERVED DURING DEVICE PREP, DURING ADVANCEMENT OR ON REMOVAL OF THE DEVICE FROM THE PATIENT? 10. WERE ANY ADDITIONAL DEFECTS OR ISSUES, OTHER THAN THE COMPLAINT ISSUE, OBSERVED ON T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003513 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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