Zimmon G22362Recalls & 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
- 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 00827002223622), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
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.
MalfunctionSep 23, 2019Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED TO CONFIRM THE INCORRECT WIRE GUIDE SIZE WAS USED. THEY TRIED TO PUT THE STENT IN THE PANCREATIC DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE PANCREATIC DUCT. THEY PULLED IT OUT OF PATIENT¿S BODY, THEY NOTICED THAT THE STENT MIDDLE SIDE HOLE WAS KINK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9102710 ↗
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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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