Zimmon G22978Recalls & 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
- 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 00827002229785), received between Aug 5, 2025 and Aug 5, 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.
MalfunctionAug 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE NURSE WAS PREPARING TO INSERT THE SPSOF-5-15 INTO THE PANCREATIC DUCT. WHILE PASSING THE SPSOF-5-15 THROUGH THE PRELOADED GUIDEWIRE (VISI2 0.025" STRAIGHT), THE WIRE CAME OUT THROUGH THE STENT HOLE AT THE PIGTAIL PART. WHILE FIXING THIS, THE PIGTAIL BENT, AND THEY HAD TO USE A NEW SPSOF-5-15. 1. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? ANS. N/A 2. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? ANS. YES 3. WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? ANS. YES 4. CAN PHOTOS OF THE DAMAGE BE PROVIDED? ANS. NO, THE PRODUCT IS DISCARDED. 5. WAS THE BENT DAMAGE NOTICED BEFORE ANY PREPARATION STEPS WERE CARRIED OUT? ANS. NO 6. WAS THE FUNCTIONALITY OF THE DEVICE TESTED PRIOR TO NOTICING THE DAMAGE? ANS. NO 7. WERE ANY PREPARATORY STEPS PERFORMED TO THE DEVICE (PER INSTRUCTIONS FOR USE, IF APPLICABLE) PRIOR TO NOTICING THE DAMAGE? ANS. THEY WERE FLUSHING THE STENT WITH STERILE DISTILLED WATER AND LOADING THE GUIDE WIRE BEFORE USING THE PRODUCT. WAS THE DEVICE STORED ACCORDING TO THE STORAGE CONDITIONS ON THE LABEL (IF APPLICABLE)? · IF NO, PLEASE DESCRIBE THE CONDITIONS OF STORAGE: ANS. THE PRODUCTS ARE STORED IN ACRYLIC DRAWERS, STACKED AC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713374 ↗
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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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