Geenen G21479Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002214798), received between Jun 7, 2016 and Jun 7, 2016 — classified as 1 injury.
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 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.
InjuryJun 7, 2016Fracture; Fracture
AFTER PLACEMENT OF A PANCREATIC STENT THE PHYSICIAN WANTED TO TAKE THE STENT OUT FROM THE WIRSUNG. SHE USED A SNARE AND PLACED IT INTO THE TABS, IT DIDN'T WORK, IT WAS LIKE THE STENT WAS IMPACTED IN THE PANCREAS. THE PHYSICIAN GRIPPED THE STENT BY THE SNARE BUT THERE WAS A STRONG RESISTANCE WHILE WITHDRAWING THE STENT, WHICH RESULTED IN THE STENT BREAKING IN HALF WITHIN THE PANCREAS. USING A PAEDIATRICS BIOPSY, THE DOCTOR RETRIEVED BOTH PARTS OF THE STENT FROM THE PATIENT. THE PATIENT IS FINE AND RETURNED HOME THE NEXT DAY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5702858 ↗
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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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