Zilver 635 G50619Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002506197), received between Nov 9, 2017 and Jun 22, 2020 — classified as 4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CAPTURE UPDATES MADE TO ANNEX D AND G CODES ON 31-OCT-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10178765 ↗
• MalfunctionFeb 27, 2019Fracture; Fracture

  DR. (B)(6) DURING PROCEDURE, THE OUTER SHEATH HAS BEEN DETACHED FROM THE HANDLE. "AS PER COMPLAINT FORM":AFTER DILATION WITH MAXPASS BALLOON 4 MM AND 6 MM THE SILVER STENT WAS INTRODUCED ALONG A 0035 VISIGLIDE WIRE. DURING THE STENT RELEASE A STRONG RESISTANCE WAS ENCOUNTERED UNTIL COMPLETE BREAK OF THE BLUE SHEET OF THE STENT NEAR THE HANDLE OF THE STENT. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373164 ↗
• MalfunctionMar 5, 2018Premature Activation; Premature Activation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'PREMATURE STENT DEPLOYMENT WITH THE SAFETY LOCK IN PLACE.' WHEN THE USER WAS ATTEMPTING PASS THE DELIVERY SYSTEM THROUGH THE STENOSED TARGET SITE, THE STENT DEPLOYED PARTIALLY. HE REMOVED IT FROM THE PATIENT AND PERFORMED ENBD INSTEAD AND COMPLETED THE PROCEDURE. THE USER COMMENTED THAT IT WAS THE DIFFICULT CASE AS THE STENOSIS AND THE ANGLE WAS SEVERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7313201 ↗
• MalfunctionNov 9, 2017Delivery System Failure; Delivery System Failure

  THE DEVICE WAS USED IN THE STENOSED HEPATIC PORTAL LESION FOR DRAINAGE OF PARTIAL LIVER. THE DELIVERY SYSTEM WAS ADVANCED INTO THE STENOSED LESION AND IT WAS ATTEMPTED TO DEPLOY. HOWEVER, IT WAS DIFFICULT TO DEPLOY THE STENT DUE TO SEVERE STENOSIS. THE USER ATTEMPTED TO KEEP DEPLOYING, THEN, THE OUTER SHEATH GOT SEPARATED FROM THE HANDLE. SINCE THE STENT WAS NOT DEPLOYED YET, THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT'S BODY. ANOTHER SIZE OF ZILVER WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012538 ↗