Zilver 635 G31486Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002314860), received between Jul 3, 2017 and Apr 25, 2018 — classified as 1 injury, 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
- Fracture1
- Kinked1
Patient problems
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2018Kinked; Kinked
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. UPON OPENING THE PACKAGE OF THE DEVICE, A KINK WAS NOTED ON THE SHEATH. THEREFORE, ANOTHER COOK'S ZILVER STENT (ANOTHER SIZE) WAS USED INSTEAD.
Patient problems: No Patient Involvement
MAUDE report 7458341 ↗InjuryJul 3, 2017Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem
THIS FOLLOW UP REPORT IS BEING SUBMITTED AS IMAGE REVIEW WAS RECEIVED. INITIAL REPORT DETAILS: ZILVER 635 SELF-EXPANDING BILIARY STENT WAS ADVANCED OVER THE WIRE GUIDE AND IT WAS ATTEMPTED TO DEPLOY. BUT AFTER THE STENT WAS DEPLOYED 3CM, THE USER COULD NOT DEPLOY THE STENT ANYMORE (THE HANDLE COULD NOT BE MANIPULATED). SO, HE REPLACED THE WIRE GUIDE FROM TERUMO/RADIFOCUS TO COIL WIRE GUIDE, HOWEVER THE SITUATION DID NOT CHANGE. SINCE THE DEVICE COULD NOT LEAVE IN THE PATIENTS' BODY, HE PULLED THE OUTER SHEATH (INTRODUCER CATHETER) TO DEPLOY THE STENT. THEN, THE OUTER SHEATH GOT SEPARATED AND REMAINED IN THE PATIENTS¿ BODY. SINCE SEPARATED PART OF THE OUTER SHEATH CONSTRICTED THE STENT, IT WAS DIFFICULT TO REMOVE THE INNER SHEATH. WHEN THE USER PULLED THE INNER SHEATH, THE TIP OF THE INNER SHEATH GOT SEPARATED AND REMAINED IN THE PLACED STENT. THE PROCEDURE ENDED AT THIS MOMENT, BUT THE FUTURE PROCEDURE IS UNDER CONSIDERATION.
Patient problems: Foreign Body In Patient
MAUDE report 6684090 ↗
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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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