Johlin G26825Recalls & 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 10827002268255), received between Mar 31, 2025 and Mar 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
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.
MalfunctionMar 31, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PROBLEM OBSERVED: DIFFICULTY PUSHING THE PROSTHESIS WITH THE CATHETER CARRIER THAT WAS BENDING AND FOLDING. NO CHANGE OF DEVICE PATIENT IMPACT: NO "AS PER CC FORM" AFTER REMOVED A JOHNIN STENT, THE DOCTOR CHOSE TO USE SPYGLASS TO BREAK STONES IN THE WIRSUNG. A LOT OF DEBRIS WAS GONE BUT SOME MAY HAVE REMAINED IN THE ENDOSCOPE WORKING CHANNEL? THEN, THE DOCTOR PLACE A JOHNIN BUT IT WAS VERY DIFFICULT TO PUSH THROUGH THE CHANNEL THE STENT. MAYBE BECAUSE OF THE DEBRIS? MAYBE BECAUSE OF THE SIZE OF THE WIRE GUIDE? (0.025'') THE DOCTOR IS USED TO PLACING THE JOHNIN BUT SAID THAT THIS TIME, IT WAS DIFFICULT TO PUSH IT AND THE PUSHING CATHETER WAS A LITTLE BIT BENDED, LIKE SOFTER THAN BEFORE? HE STILL MANAGED TO PUT THE STENT IN THE WIRSUNG. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730214 ↗
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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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