Zilver 635 G36021Recalls & 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 10827002360218), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionDec 17, 2018Break; Break
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: FOR AN SFA PROCEDURE THE ZILVER 635 BILIARY SELF-EXPANDING STENT, G36021, WAS USED. STENT DEPLOYED, APON REMOVAL OF DELIVERY SYSTEM, RESISTANCE AND DELIVERY SYSTEM CAME APART. FOLLOW UP CUSTOMER RELATION REQUESTED HOW THEY WERE ABLE TO REMOVER THE PART OF THE DEVICE THAT BROKE. DISTRICT MANAGER REPLY PER CUSTOMER: DELIVERY HANDLE CAME OFF SO THEY PULLED ON REMAINING SHEATH. (B)(6) 23OCT2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8168498 ↗
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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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