Cotton-Leung G21988Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002219885), received between May 22, 2019 and May 23, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration2
- Inaccurate Flow Rate1
Patient problems
- No Known Impact Or Consequence To Patient2
- Perforation1
- Sepsis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2019Inaccurate Flow Rate; Migration; Inaccurate Flow Rate; Migration
THE FOLLOWING WAS EXTRACTED FROM THE COMPLAINT FORM DRAFTED BY AREA REP: "ERCP PERFORMED NOTED MIGRATED BILIARY STENT WHICH WAS THEN REMOVED. THE EXISTING STENT WAS FLUSHED OUT AND DEBRIS REMOVED, AND THEN PULLED OUT SLIGHTLY MORE TO ACHIEVE BETTER BILE DRAINAGE." ADDITIONAL INFORMATION HAS BEEN RECEIVED AND INVESTIGATION IS BEING UPDATED.
Patient problems: No Known Impact Or Consequence To Patient; Sepsis
MAUDE report 8636405 ↗InjuryMay 22, 2019Migration; Migration
[20190425 MARTIN NG]. 7 FRENCH BILIARY STENT APPEARS TO HAVE MIGRATED WITH DISTAL END ABUTTING THE DUODENAL WALL. IT WAS REMOVED WITH FORCEPS. PATIENT TOLERATED PROCEDURE. [20190424 MARTIN NG]. ACCORDING TO AREA REPRESENTATIVE, THE STENT WAS PLACED A FEW WEEKS AGO. FEW WEEKS LATER AFTER PLACEMENT, THE STENT WAS FOUND TO BE MIGRATED. EVENT IS FDA MDR REPORTABLE BASED ON THE REQUIREMENT FOR 'SURGICAL INTERVENTION' TO REMOVE THE DEVICE AND ALSO BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT MIGRATION'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Patient problems: No Known Impact Or Consequence To Patient; Perforation
MAUDE report 8632435 ↗
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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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