Geenen G21575Recalls & reported problems
Cook Ireland Ltd · Geenen, Pancreatic Stent Set · 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 00827002215757), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2018Fracture; Fracture
THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE" THE DEVICE WAS TO BE PLACED IN THE BILE DUCT. THE USER FOUND THAT THE STENT WAS FRAYED DURING AN INSPECTION PRIOR TO USE, SO ANOTHER DEVICE WAS USED INSTEAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7974122 ↗
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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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