Zilver 635 G50616Recalls & reported problems
Cook Ireland Ltd · Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System · Class 2 · Implant
All models of Zilver 635 (55)
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 10827002506166), received between Aug 28, 2018 and Aug 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
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.
MalfunctionAug 28, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
REPORT IS BEING SUBMITTED UNDER THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE¿. ERCP WAS COMPLETED. UPON PLACING TWO SIDE BY SIDE STENTS, THE SECOND STENT (EVEN AFTER LUBRICATION) THERE WAS RESISTANCE AND IT WAS NOTICED THAT THE STENT HAD PARTIALLY ADVANCED OUT OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND THE STENT CAME OUT WITH THE DELIVERY SYSTEM FULLY "INTACT." ANOTHER DEVICE WAS PLACED TO COMPLETE THE ORIGINALLY INTENDED PROCEDURE. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7821932 ↗
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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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