Zilver 635 G36245Recalls & reported problems
Cook Ireland Ltd · Zilver 635 Biliary Stent · Class 2 · Implant
All models of Zilver 635 (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002362458), received between Oct 18, 2016 and Mar 14, 2017 — classified as 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2017Fracture; Fracture
THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL REPORT DETAILS: ON (B)(6) 2017 THE PATIENT HAD AN OPTION FILTER PLACED AND RECEIVED LYSIS OVERNIGHT. PATIENT BROUGHT BACK (B)(6) 2017 AND HAD PROCEDURE TO THE LEFT COMMON ILIAC TO TREAT MAY THURNERS. A 14X80 ZILVER 635 WAS PLACED AND IT DID NOT COVER ALL OF THE LESION. AFTER BALLOONING, THERE WAS A NEED FOR A ADDITIONAL STENT AND A ZILVER 635 14X60 WAS PLACED. BALLOONED POST STENT AND COMPLETED. (B)(6) 2017 THE PATIENT WAS BROUGHT BACK FOR FILTER RETRIEVAL AND IT WAS NOTICED THAT THE 14X60 STENT WAS FRACTURED AND ATTACHED BY JUST A FEW STRANDS. AFTER REVIEWING THE (B)(6) 2017 FILMS WITH THE PHYSICIAN, IT WAS NOTICED THAT WHEN THE 14X60 STENT WAS PLACED, THE STENT WAS PUT UNDER THE STRESS DUE TO THE HIGHLY STENOTIC LESION. THIS WAS NOT SEEN WHEN INITIALLY PLACED. QUESTION REMAINS ON NEXT STEPS AND VASCULAR SURGERY HAS BEEN CONSULTED. FILTER RETRIEVAL WAS ABORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6401887 ↗MalfunctionOct 18, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE STENT DID NOT DEPLOY UNIFORMLY. THE STENT REMAINED WHERE PLACED AND DID NOT STRAIGHTEN POST DILATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6035889 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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