Fusion Zilver G31563Recalls & reported problems
Cook Incorporated · Fusion Zilver Biliary Stent System · Class 2 · Implant
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 10827002315638), received between Jul 8, 2016 and Jul 8, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 or Delayed Positioning1
- Separation Failure1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2016Difficult or Delayed Positioning; Separation Failure; Difficult or Delayed Positioning; Separation Failure
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK FUSION ZILVER BILIARY STENT SYSTEM. AS REPORTED TO CUSTOMER RELATIONS, "THE FACILITY HAD EXTREME DIFFICULTY DEPLOYING THE STENT AND REMOVING THE INTRODUCER POST DEPLOYMENT FROM THE STENT. AFTER EXPERIENCING THE EXTREME DIFFICULTY DEPLOYING THE STENT, THE PHYSICIAN ELECTED TO STOP THE PROCEDURE AND BENCH TOP TEST A NEW COOK FUSION ZILVER BILIARY STENT SYSTEM. THE PHYSICIAN AT THIS TIME REALIZED HE WAS DOING EVERYTHING CORRECTLY AND RESUMED THE INTENDED PROCEDURE; ULTIMATELY COMPLETING THE PROCEDURE SUCCESSFULLY WITH THE COMPLAINT DEVICE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5780297 ↗
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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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