Zimmon G21426Recalls & reported problems
Cook Ireland Ltd · Zimmon, Pancreatic 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 00827002214262), received between Sep 9, 2025 and Sep 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
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.
MalfunctionSep 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
AFTER PLACING A GUIDEWIRE (BOSTON SCIENTIFIC/ENDOSELECTOR 0.025 INCH) IN THE PANCREATIC DUCT, WHEN ADVANCING A STENT OVER THE GUIDEWIRE, THE GUIDEWIRE DID NOT EXIT THE GUIDEWIRE LUMEN OF THE STENT BUT INSTEAD EXITED THE GUTTER, MAKING IT UNUSABLE. THE PROCEDURE CONTINUED USING A DIFFERENT MODEL GEPD (DETAIL UNKNOWN). THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO HEALTH HAZARD. 1.DOES THE COMPLAINT RELATE TO: DEVICE PLACEMENT/DEVICE REMOVAL/OBSERVATION PRIOR TO PATIENT CONTACT DURING ADVANCING OVER A WIRE GUIDE. 2 WHAT WAS THE TARGET LOCATION FOR THE STENT? THE PANCREATIC DUCT. 3 PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. 4 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? BOSTON SCIENTIFIC/ENDOSELECTOR 0.025INCH. 5 WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 6 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. 7 WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 8 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? UNKNOWN. 10 DID
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004331 ↗
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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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