Geenen G22466Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002224667), received between Feb 7, 2019 and Feb 27, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (2 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, 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
- Off-Label Use2
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2019Off-Label Use; Off-Label Use
THE GPSO-7-11 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-7-11 DISTAL FLAP WAS FOLDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8373321 ↗MalfunctionFeb 7, 2019Off-Label Use; Material Deformation; Off-Label Use; Material Deformation
THE GPSO-7-11 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-7-11 DISTAL FLAP WAS FOLDED. NO SIDE EFFECTS TO THE PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8314878 ↗
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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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