Zimmon G21529Recalls & reported problems
Cook Ireland Ltd · Zimmon, Biliary Stent Set · 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 00827002215290), received between Apr 5, 2018 and Jan 6, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Kinked1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2020Difficult to Advance; Difficult to Advance
THEY TRY TO PUT THE STENT INTO THE GUIDE WIRE BUT IT CANNOT GO THROUGH, SO THEY USE ANOTHER NEW DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9552333 ↗MalfunctionApr 5, 2018Kinked; Kinked
THE DEVICE WAS TO BE PLACED IN THE PRTA HEPATIS REGION FOR BILIARY DRAINAGE. THE STENT GOT KINKED WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. REPORTING DUE TO THE PRECEDENCE FOR "STENT KINKED/BENT" FOR THIS PRODUCT FAMILY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7398611 ↗
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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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