Cotton-Leung G21683Recalls & 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
- 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 00827002216839), received between May 5, 2017 and May 5, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE DEVICE WAS RETURNED AND EVALUATED. THEY USED TO PLACE STENT AFTER AT THE DISTAL OF THE COMMON BILE DUCT STRICTURE SITE. 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 6546821 ↗
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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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