Cotton-Leung G21621Recalls & 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 00827002216211), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Perforation” (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
- Material Perforation1
- Use of Device Problem1
Patient problems
- Bowel Perforation1
- Peritonitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2020Use of Device Problem; Material Perforation; Use of Device Problem; Material Perforation
PATIENT WAS COMMITTED BY HOSPITAL BECAUSE OF COMMON BILE DUCT STONE AND ACUTE CHOLANGITIS. USER FACILITY CONDUCTED ERCP ON (B)(6) 2019 AND IMPLANTED STENT IN BILE DUCT DUE TO OBSTRUCTION OF BILIARY TRACT AS WELL AS TOO MANY STONE WHICH CAUSE STONE REMOVAL DIFFICULTY. THE JAUNDICE WAS RELIEVED AFTER THE PROCEDURE. USER VISITED HOSPITAL ON (B)(6) 2019 DUE TO STOMACHACHE, FECAL REDUCE. USER FACILITY CHECKED ABDOMEN DR WITH NO ABNORMALITY, AND CONSIDERED THE POSSIBILITY OF INTESTINAL ADHESION. USER FACILITY RELAXING THE BOWELS TO EASE THE STOMACHACHE, FECAL REDUCE. PATIENT VISITED HOSPITAL ON (B)(6) 2019 BECAUSE THE STOMACHACHE WAS GETTING WORSE WHICH IS CONSIDERED AS PERITONITIS, AND USER FACILITY INJECTED PIPERACILLIN SODIUM TAZOBACTAM SODIUM AS ANTI-INFECTION TREATMENT TO ALLEVIATE SYMPTOMS. USER FACILITY DETECTED THE STENT PENETRATED THE INTESTINAL WALL AFTER CT SCAN, THEN INSERTING STOMACH TUBE AS DECOMPRESSION, AND REMOVE THE STENT UNDER GENERAL ANESTHESIA WITH GASTROSCOPE, AND MEANWHILE FIXED THE DUODENAL PERFORATION WITH TITANIUM CLIP. PATIENT WAS ON FASTING AFTER STENT REMOVAL AND TOOK PIACILLIN TAZOBATAM 4.5 Q8H AS ANTI-INFECTION TREATMENT FOR 5 DAYS, THEN WAS DISCHARGED BY H
Patient problems: Bowel Perforation; Peritonitis
MAUDE report 9615568 ↗
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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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