Zilver 518 G43792Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002437927), received between Jan 12, 2017 and Feb 3, 2026 — 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 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.

• MalfunctionFeb 3, 2026Off-Label Use; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-MAR-26. RESPONSE TO THE BELOW QUESTIONS WAS RECEIVED ON 05-FEB-2026: DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? - 6 FR SHUTTLE CORK. WHAT WAS THE TARGET LOCATION FOR THE STENT? - RIGHT TRANSVERSE SINUS. WHAT WAS THE ACCESS SITE CHOSEN? - RT FEMORAL ARTERY. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? - ARISTOLE 0.014. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? - NO. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? - NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? - NONE. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? - YES , SAME DAY. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G., KINK)? - NO. WAS THE STENT BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT? - NO. DID ANY PART OF THE PRODUCT SNAG/GET CAUGHT ON THE STENT WHEN REMOVING THE DELIVERY SYSTEM? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247066 ↗
• MalfunctionJan 12, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT UPON DEPLOYING THE STENT, WHICH WAS SUPPOSED TO BE A 10X60 ZILVER 518, THE PHYSICIAN AND THE STAFF NOTICED IT LOOKED MORE LIKE A 30MM STENT, ESPECIALLY WHEN BALLOONING IT WITH AN 8X4 BALLOON. ANOTHER 10X60 ZILVER STENT WAS USED (LOT #C1232735), AND WHEN PUT INSIDE THE PREVIOUSLY PLACED ONE, IT WAS TWICE AS LONG. NO PRODUCT WILL BE RETURNED. IMAGES WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6245039 ↗