Zimmon G22979Recalls & reported problems
Cook Ireland Ltd · Zimmon Pancreatic Stent · Class 2 · Implant
All models of Zimmon (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002229792), received between May 4, 2017 and Jun 15, 2017 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break2
- Fracture2
- Migration or Expulsion of Device2
Patient problems
- No Code Available3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2017Break; Fracture; Break; Fracture
PLASTIC STENT WAS CUT OFF. ADDITIONAL INFO RECEIVED 22 MAY 2017: THEY WANTED TO READJUST PANCREATIC STENT. SO THEY USED FORCEP AND ADJUSTED THE POSITION. BUT PANCREATIC STRICTURE WAS SO TIGHT, SO STENT WAS CUT OFF. AND THEY REMOVED STENT FRACTURED.
Patient problems: No Code Available
MAUDE report 6642872 ↗InjuryJun 15, 2017Break; Fracture; Break; Fracture
PLASTIC STENT WAS CUT OFF. ADDITIONAL INFO RECEIVED FROM REP VIA EMAIL 22 MAY 2017: THEY WANTED TO READJUST PANCREATIC STENT. SO THEY USED FORCEP AND ADJUSTED THE POSITION. BUT PANCREATIC STRICTURE WAS SO TIGHT, SO STENT WAS CUT OFF.
Patient problems: No Code Available
MAUDE report 6642681 ↗InjuryMay 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
THEY USED TO PLACE STENT AFTER THE PANCREATIC DUCT STRICTURE SITE. THEY WERE ABLE TO CONFIRM THE STENT MIGRATION IMMEDIATELY AFTER PLACEMENT OF THE STENT. SO THEY REMOVED MIGRATION STENT.
Patient problems: No Code Available
MAUDE report 6568449 ↗InjuryMay 4, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
THEY USED TO PLACE STENT AFTER THE PANCREATIC DUCT STRICTURE SITE. THEY WERE ABLE TO CONFIRM THE STENT MIGRATION IMMEDIATELY AFTER PLACEMENT OF THE STENT. SO THEY REMOVED MIGRATION STENT.
Patient problems: Foreign Body In Patient
MAUDE report 6543369 ↗
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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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