Zimmon G21404Recalls & reported problems
Cook Ireland Ltd · Zimmon Biliary 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 00827002214040), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dent in Material” (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.
Reports received per month
Most reported problems
Device problems
- Dent in Material1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
THE STENT DIFFICULT TO PUSH THO THE CHANNEL, NEED TO REMOVE THE ENDOSCOPE FROM THE PATIENT AND REMOVE THE STENT FROM THE DISTAL END OF THE ENDOSCOPE CHANNEL. THE STENT TERRIBLY KINKED. 1.WHAT WAS THE TARGET LOCATION FOR THE STENT? DISTAL OF CBD. 2. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. IN CABINET OF OT , WITH TEMPERATURE AND HUMIDITY CONTROL. 3. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? METII-35-480. 4. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? N/A, YES, NO, WATER. 5. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? N/A, YES, NO, NO. 6. WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? N/A, YES, NO, NO. 7. WERE PREVIOUS PROCEDURES I.E., SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? N/A, YES, NO (IF YES, PLEASE INDICATE THE PROCEDURE PERFORMED.) SPHINCTEROTOMY HAS BEEN PERFORMED BEFORE PLACING STENT. 8. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? N/A, YES, NO, NO. 9. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22198666 ↗
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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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