Johlin G26828Recalls & reported problems
Cook Ireland Ltd · Johlin, Pancreatic Wedge Stent · Class 2 · Implant
Data updated Oct 16, 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 10827002268286), received between May 5, 2025 and May 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Off-Label Use; Off-Label Use
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A BILIARY PROCEDURE TO PLACE A SENT IN THE LIVER IN WHICH THE JOHLIN PANCRATIC WEDGE STENT, G26828, WAS PLACED. WHEN THE PHYSICIAN WENT TO DEPLOY THE STENT, THE INTRODUCER BENT AND BROKE. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AND CONFIRMED STENT DEPLOYED WHERE INTENDED. PHYSICIAN WAS ABLE TO DEPLOY STENT AND CONFIRMED STENT DEPLOYED WHERE INTENDED. DOES THE COMPLAINT RELATE TO: · DEVICE PLACEMENT THIS ONE · DEVICE REMOVAL · OBSERVATION PRIOR TO PATIENT CONTACT IF NOT, WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? PHYSICIAN WAS ABLE TO USE THE DEVICE IN QUESTION. WHAT WAS THE TARGET LOCATION FOR THE STENT? STENT PLACED IN LIVER PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED IN A CLOSET WHERE IT IS DRY AND COOL. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? WIRE WAS AN E-Z GLIDE, SIZE NOT PROVIDED BY END USER WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960287 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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