Cotton-Leung G21807Recalls & 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
- 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 00827002218079), received between May 17, 2017 and Feb 7, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 18, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8314880 ↗InjuryMay 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
THEY WERE ABLE TO CONFIRM THE STENT MIGRATION IMMEDIATELY AFTER PLACEMENT OF THE STENT. SO THEY REMOVED MIGRATION STENT.
Patient problems: Foreign Body In Patient
MAUDE report 6571763 ↗
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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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