Zilver 635 G32006Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002320069), received between Jul 9, 2019 and May 2, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2025Material Twisted/Bent; Material Twisted/Bent
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-JUL-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21949421 ↗MalfunctionJul 9, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
TERUMO'S RADIFOCUS 0.035" WIRE GUIDE WAS INSERTED IN A PRE-EXISTNG 8FR DRAINAGE CATHETER. THE WIRE GUIDE PASSED THROUGH THE STENOSIS, SO THE DRAINAGE CATHETER WAS REMOVED FROM THE BODY AND MEDIKIT'S 6FR SUPAR SHEATH ADVANCED OVER THE WIRE GUIDE. THEN, ZIB6-40-10.0-80, ZIB6-40-10.0-50, ZIB6-40-10.0-40 WERE PLACED IN THIS ORDER FROM THE PROXIMAL SIDE. AFTER THAT THE USER ATTEMPTED TO ADVANCE ZIB6-40-10.0-60/LOT C1482126 BUT THE DELIVERY SYSTEM GOT CAUGHT BY THE EDGE OF THE PROXIMAL STENT(ZIB6-40-10.0-80) AND IT DID NOT ADVANCE ANY FURTHER. THE USER TRIED SOME WAYS(CHANGE WIRE GUIDES ETC. ) TO ADVANCE THE DELIVERY SYSTEM BUT IT DID NOT ADVANCE AT ALL. THE USER DECIDED NOT TO PLACE ZIB6-40-10.0-60 AND FINISHED THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8771331 ↗
Other Stents, drains and dilators for the biliary ducts devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page