Zilver 635 G36235Recalls & reported problems
Cook Ireland Ltd · Zilver 635 Biliary Stent · 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 10827002362359), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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
- Premature Activation1
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.
MalfunctionSep 20, 2017Premature Activation; Premature Activation
THE TECH OPENED UP THE BOX AND THEN THE STERILE PACKAGING FOR THE DOCTOR TO PULL OUT THE DEVICE. WHEN THEY WERE READY TO PREP, PULLED OUT OF THE HOLDER AND NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. ANOTHER DEVICE WAS USED FOR THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6878293 ↗
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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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