Cotton-Huibregtse G21881Recalls & reported problems
Cook Ireland Ltd · Cotton-Huibregtse Biliary Stent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002218819), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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
- Kinked1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2018Kinked; Kinked
DURING INSERTION OF STENT AND INTRODUCER INTO SCOPE, STENT WOULD BUCKLE UPON INSERTION INTO WIRE LOCKING CAP. TECH REMOVED THE STENT AND GRABBED ANOTHER STENT AND PHYSICIAN PLACED STENT WITHOUT DIFFICULTY. THEY WENT TO PLACE ANOTHER STENT FOR THIS PROCEDURE AND IT DID NOT BUCKLE. IT WAS PLACED SUCCESSFULLY. DM OBSERVED PHYSICIAN HAVING DIFFICULTY INSERTING FIRST STENT INTO SCOPE. THEN DM GOT CLOSER TO PHYSICIAN AND NOTICED STENT BUCKLING AT THE DISTAL FLAP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7163216 ↗
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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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