Zilver 635 G50617Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002506173), received between Mar 1, 2017 and Apr 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 16-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16782882 ↗
• MalfunctionJan 14, 2020Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  THERE WAS STENOSIS (3CM IN LENGTH) IN THE UPPER BILE DUCT. THE DELIVERY SYSTEM OF THE ZILBS WAS ADVANCED TO THE TARGET SITE OVER OLYMPUS'S WIRE GUIDE VISIGLIDE 0.025INCH, BUT THE TIP OF THE DELIVERY SYSTEM BECAME CAUGHT ON THE STENOSIS, WHICH MADE THE USER UNABLE TO ADVANCED IT ANY FURTHER AND THE TIP OF THE DELIVERY SYSTEM BECAME DEFORMED AS WELL. THEREFORE, ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DELIVERY SYSTEM KINKS'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9586067 ↗
• MalfunctionMar 1, 2017Premature Activation; Premature Activation

  THE PATIENT HAD PREVIOUSLY HAD RECONSTRUCTION(ROUX-EN-Y) AFTER GASTRECTOMY AND THE DOCTOR SELECTED ZILVER 635 BILIARY SELF EXPANDING METAL STENT TO TREAT HIS MALIGNANT STRICTURE OF THE INTRAHEPATIC BILE DUCT. EST WAS NOT PERFORMED. ZILBS-635-8-4 WAS INSERTED AND ADVANCED TO THE TARGET SITE USING A DOUBLE BALLOON ENDOSCOPE (FUJI FILM'S EI-530B). HOWEVER THE ANATOMY WAS SEVERE AS THE SCOPE POSITION WAS AS 'LOOPED' AND THE ADVANCING THE DELIVERY SYSTEM WAS DIFFICULT WITH STRONG RESISTANCE. THE USER SAW ONLY THE INNER CATHETER WAS ADVANCED FROM THE SHEATH, SO HE DECIDED NOT TO CONTINUE TO USE THIS DEVICE. HE REMOVED THE DELIVERY SYSTEM AND REPLACED IT WITH ZILBS-635-10-4, BUT HE EXPERIENCED THE SAME DIFFICULTY. HE DISCONTINUED THE PROCEDURE WITHOUT PLACING ANY STENTS AND PLANNED PLACING STENTS PERCUTANEOUSLY FOR THE NEXT TIME. WHEN WASHING THE ENDOSCOPE AFTER THE PROCEDURE, A STENT WAS FOUND IN THE SCOPE CHANNEL. THE USER WAS NOT SURE WHEN IT WAS DEPLOYED FROM THE DELIVERY SYSTEM OR IF IT WAS FROM 8-4 OR 10-4, BUT THEY DISCARDED BOTH DEVICES INCLUDING THIS DEPLOYED STENT. THE RED SAFETY TAB WAS NOT REMOVED. AS THERE ARE TWO SUSPECTED DEVICES INVOLVED IN THIS EVENT A SEPARATE REPORT HAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6367565 ↗