Cotton-Leung G27122Recalls & reported problems
Cook Ireland Ltd · Cotton-Leung Biliary Stent Set · 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 00827002271227), received between May 23, 2019 and May 23, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Known Impact Or Consequence To Patient1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2019Migration; 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. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Patient problems: No Known Impact Or Consequence To Patient; Sepsis
MAUDE report 8636356 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page