Zimmon G21394Recalls & 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
- 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 00827002213944), received between May 28, 2019 and May 28, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- 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.
MalfunctionMay 28, 2019Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation
THE STENT HAS BEEN DAMAGED WHEN ATTEMPTING PASSAGE ON GUIDE WIRE: RIP OF THE DEVICE AT THE LEVEL OF 3 EYES, CONSEQUENCES: THEY USED ANOTHER DEVICE. "AS PER COMPLAINT FORM": THE STENT HAS BEEN DAMAGED WHEN ATTEMPTING PASSAGE ON WIRE GUIDE THEY TAKE ANOTHER DEVICE FDA MDR REPORT IS REQUIRED: INCIDENT MEETS REPORTING CRITERIA BASED ON "STENT KINKED/BENT". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REPORTABILITY RE-ASSESSMENT MAY BE REQUIRED ON RECEIPT OF ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8646310 ↗
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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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