Zilver Flex 35 G50165Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002501659), received between Mar 22, 2017 and Aug 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 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.

• MalfunctionAug 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING ANGIOPLASTY AND STENT PLACEMENT OF THE LEFT SUPERFICIAL FEMORAL ARTERY, THE HANDLE OF A ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT SEPARATED FROM THE SHEATH. ACCESS WAS OBTAINED FROM THE RIGHT FEMORAL ARTERY. THE SHEATH REPORTEDLY BECAME DETACHED FROM THE HANDLE DURING STENT DEPLOYMENT. IT WAS LATER NOTED THAT THE TECH WAS REPORTEDLY HOLDING ON TO THE STENT SHEATH IN ADDITION TO THE VASCULAR SHEATH AT THE SAME TIME THAT THE PHYSICIAN WAS PULLING BACK ON THE HANDLE TO "UNSHEATHE THE STENT". THE PHYSICIAN PULLED ON THE REMAINING PORTION OF THE STENT SHEATH TO "UNSHEATHE THE STENT". THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8911197 ↗
• MalfunctionMar 22, 2017Material Separation; Material Separation

  IT WAS REPORTED, DURING A RIGHT SFA INTERVENTION, UPON DEPLOYING THE ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT, THE BLACK HUB DETACHED FROM THE DEPLOYMENT SYSTEM. THE STENT WAS ABLE TO BE DEPLOYED AS INTENDED WITHOUT ANY ISSUES IN THE TARGET SITE. IT WAS REPORTED THAT THE DEVICE WAS FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE. PRE-DILATION WAS CONDUCTED BEFORE THE STENT DEPLOYMENT. THE REPORTER STATED THAT THE TARGET SITE WAS SEVERELY CALCIFIED AND THERE WAS A STEEP BIFURCATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6424819 ↗