Zimmon G22456Recalls & 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
- 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 00827002224568), received between Mar 27, 2019 and May 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Difficult to Advance1
- Use of Device Problem1
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.
MalfunctionMay 16, 2019Break; Use of Device Problem; Break; Use of Device Problem
BEFORE THE P-DUCT STENT INSERTION, THE NURSE TRIED TO PASS WIRE THROUGH TO SPSOF-7-9. BUT CURVED PART WAS A BIT TEARING. (SIDE HOLE WAS LARGER THAN NORMAL)
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8615562 ↗MalfunctionMar 27, 2019Difficult to Advance; Difficult to Advance
THEY TRIED TO PUT THE SPSOF-7-9 IN THE PANCREATIC DUCT FOR DRAINAGE, BUT THE SPSOF-7-9 COULD NOT PASS THE STRICTURE IN THE PANCREATIC DUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8455060 ↗
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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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