Geenen G22321Recalls & reported problems
Cook Ireland Ltd · Geenen Pancreatic 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 00827002223219), received between Nov 8, 2018 and Nov 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
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.
MalfunctionNov 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
ADDITIONAL INFORMATION RECEIVED ON THE 11-OCT-18 CONFIRMING THAT THE STENT MIGRATED. THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION "STENT MIGRATION" AS PER PROBLEM STATEMENT: (B)(6) FROM THE HOSPITAL EMAILED ABOUT PROBLEMS WITH 2 PANCREATIC STENTS. REP WILL CONFIRM THE CORRECT RPN AND LOT AFTER VISITING THE HOSPITAL TOMORROW. THE FLAPS IN THE STENT WERE NOT OPEN ENOUGH AND IT WAS DIFFICULT TO USE THEM. THEY HAD THIS ISSUE WITH 2 PATIENTS, BUT THEY WERE ABLE TO USE THE STENTS. NOT AVAILABLE FOR RETURN. "AS PER COMPLAINT FORM": THE STENT WAS LEFT IN THE PANCREATIC DUCT AS IT WAS INTENDED. ENDOSCOPIC PANCREATIC STENTING PROCEDURE. STENT'S FLAPS WERE SO FLAT THAT THE STENT MIGRATED IN, AND IT HAD TO BE MANIPULATED SEVERAL TIMES. FINALLY FLAP OPENED AGAINST PAPILLA AND STENT WAS LEFT IN THE PANCREATIC DUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8050942 ↗
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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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