Zilver 635 G36230Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002362304), received between May 31, 2017 and May 31, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2017Break; Material Separation; Break; Material Separation

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF ADDITIONAL INFORMATION RELATING TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: THE EVENT DESCRIPTION REFERS TO AN "ILIAC PROCEDURE". WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE? THE TARGET LOCATION WAS THE LEFT ILIAC ARTERY. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? THERE WAS NO RESISTANCE WHEN ADVANCING THE DELIVERY SYSTEM. INITIAL REPORT DETAILS: AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ILIAC PROCEDURE WHEN DEPLOYING THE SHEATH SEPARATED FROM THE HUB. THERE WAS NO HARM TO THE PATIENT. THE STENT HAD NOT DEPLOYED YET AND THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE AND USE ANOTHER WITH NO FURTHER COMPLICATIONS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600840 ↗