Zilver 635 G36009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002360096), received between Jun 13, 2017 and Jul 31, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  REPORT IS BEING SUBMITTED UNDER REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE DEPLOYMENT WITH SAFETY LOCK IN PLACE" THE DELIVERY SYSTEM OF THE COMPLAINT DEVICE WAS ADVANCED OVER TERUMO'S RADIFOCUS 0.035" WHICH WAS PREVIOUSLY PLACED IN THE PATIENT, BUT THE PHYSICIAN DECIDED TO CHANGE THE WIRE GUIDE BEFORE THE DELIVERY SYSTEM REACHED TO THE PATIENT BODY. HE ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM THOUGH, IT WAS STUCK ON THE WIRE GUIDE AND BECAME IMPOSSIBLE TO BE WITHDRAWN. THEREFORE, THE WIRE GUIDE WITH THE DELIVERY SYSTEM MOUNTED WAS CUT AT A CERTAIN POINT OUTSIDE THE PATIENT BY THE PHYSICIAN, AND THESE DEVICES WERE REMOVED AS A UNIT. THE REST OF THE CUT WIRE GUIDE WAS REMOVED FROM THE PATIENT AND CHANGED WITH ANOTHER WIRE GUIDE, THEN ANOTHER STENT WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7734241 ↗
• MalfunctionJun 13, 2017Material Separation; Activation, Positioning or Separation Problem; Material Separation; Activation, Positioning or Separation Problem

  PTBS(PERCUTANEOUS TRANSHEPATIC IMPLANTATION OF BILIARY STENT) WAS PERFORMED. WHEN THE PHYSICIAN WAS ATTEMPTING TO PASS THE DELIVERY SYSTEM OF THE COMPLAINT DEVICE THROUGH THE STENOSIS IN THE COMMON BILE DUCT, IT GOT STUCK IN THE STENOSED PART. HE PULLED BACK THE DEVICE WITH STRONG FORCE TO GET IT OUT OF THE STENOSIS, BUT THE OUTER SHEATH OF THE SYSTEM GOT SEPATRATED FROM THE HANDLE THEN. THE SYSTEM WAS RETRIEVED OUT OF THE PATIENT SUCCESSFULLY. AS THE STENOSIS COULD NOT BE PASSED THROUGH, PTBS WAS CANCELED AND PTBD WAS PERFORMED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6636380 ↗