Cotton-LeungRecalls & reported problems across all models
Cook Ireland Ltd · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 21 models of Cotton-Leung by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2016 and Oct 28, 2025 — classified as 17 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cotton-Leung problems
Device problems
- Migration or Expulsion of Device12
- Difficult to Advance7
- Failure to Advance3
- Material Deformation3
- Material Perforation3
- Migration3
- Break2
- Use of Device Problem2
Patient problems
- No Known Impact Or Consequence To Patient13
- Foreign Body In Patient5
- No Code Available5
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient3
- Bacterial Infection2
- Perforation2
- Sepsis2
Cotton-Leung models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cotton-Leung G21469CATHETER, BILIARY, DIAGNOSTIC4 reports
- Cotton-Leung G22622CATHETER, BILIARY, DIAGNOSTIC3 reports
- Cotton-Leung G21472CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21474CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21807CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21810CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21818CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21979CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21988CATHETER, BILIARY, DIAGNOSTIC2 reports
- Cotton-Leung G21467CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21621CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21673CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21683CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21684CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21685CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21811CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21813CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G21987CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G22011CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G27122CATHETER, BILIARY, DIAGNOSTIC1 report
- Cotton-Leung G27146CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Cotton-Leung adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Failure to Advance; Failure to Advance
WHEN DOCTOR INSERTED STENT INTO CBD, STENT WAS NOT INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402123 ↗MalfunctionOct 27, 2025Failure to Advance; Failure to Advance
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 28-OCT-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399534 ↗MalfunctionAug 14, 2025Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 02-OCT-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812762 ↗MalfunctionAug 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
WHEN THE DOCTOR INSERTED STENT INTO CBD, STENT WAS NOT INSERTED. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. ERCP PRODUCT CABINET (SHADED AREA) *WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? OLYMPUS VISIGLIDE2 0.025¿ 450CM. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. WERE PREVIOUS PROCEDURES I.E., SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? HE DID SPHINCTEROTOMY. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS TJF-260V 4.2MM. DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? NO. *WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22781451 ↗MalfunctionFeb 7, 2020Difficult to Advance; Difficult to Advance
WHEN THEY DO THE ERCP STONE CASE, ACROBAT2 WAS USED. TO OBTAIN OCCLUSION IMAGE OF BILE AND HEPATIC DUCT, THE NURSE INJECTED CONTRAST. AND THEY EXCHANGED BALLOON FOR INSERT STENT(CLSO-10-9) TO DRAIN. HOWEVER , THE WIRE COULDN'T MOVE AT ALL . SO THE NURSE WAS A BIT UPSET AND REMOVED THE WIRE AND BALLOON SIMULTANEOUSLY. AND RE-CANNULATE VIA BALLLOON AND ACROBAT2 AND SUCCEED. AFTER WIRE LEFT, STENT FOLLOWED THE WIRE TO INSERT THE DUCT. BUT THE STENT COULDN'T MOVE FORWARD BECAUSE OF THE RESISTANCE OF WIRE COATING. SO THEY REMOVED BOTH(STENT AND WIRE)
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9680450 ↗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 ↗MalfunctionJul 12, 2019Material Deformation; Material Deformation
NEAR THE TAPERED TIP SIDE HOLE WAS BENT. NO ADVERSE PATIENT EFFECTS. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8783918 ↗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 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 ↗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 ↗MalfunctionFeb 7, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8314880 ↗MalfunctionOct 11, 2018Difficult to Advance; Difficult to Advance
THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE OF "DIFFICULT ADVANCEMENT" THEY TRIED TO PUT THE CLSO-8.5-12 IN TO THE INTRAHEPATIC DUCT, BUT THE CLSO-8.5-12 COULD NOT PASS THROUGH THE STRICTURE IN THE INTRAHEPATIC DUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7955417 ↗MalfunctionOct 11, 2018Difficult to Advance; Difficult to Advance
THIS FILE IS BEING SUBMITTED BASED ON THE FDA MDR PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. THEY TRIED TO PUT THE CLSO-7-9 IN TO THE BILE DUCT, BUT THE CLSO-7-9 COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7955322 ↗MalfunctionAug 16, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT". THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7788412 ↗MalfunctionAug 16, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
THIS COMPLAINT IS BEING REPORTED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT". THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7788247 ↗
Other Cook Ireland Ltd products
All Cook Ireland Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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