Cotton-Leung G21469Recalls & reported problems
Cook Ireland Ltd · Cotton-Leung Biliary Stent · Class 2 · Implant
All models of Cotton-Leung (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002214699), received between Dec 18, 2017 and Oct 27, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance2
- Failure to Advance2
- Material Deformation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Failure to Advance; Failure to Advance
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 28-OCT-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399534 ↗MalfunctionAug 14, 2025Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 02-OCT-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812762 ↗MalfunctionAug 16, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
THIS COMPLAINT IS BEING REPORTED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT". THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7788247 ↗MalfunctionDec 18, 2017Use of Device Problem; Use of Device Problem
STENT DID NOT GO THROUGH THE WIRE LOCK. WIRE LOCK AND STENT ONLY TO BE RETURNED. "AS PER COMPLAINT FORM": THE STENT COULD NOT BE PUSHED THROUGH THE VALVE OF THE WIRE LOCK. IT WORKED WITH AN 8.5 FRENCH STENT THOUGH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7126837 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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