Zilver 635 G43851Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002438511), received between Jul 17, 2017 and Apr 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivery System Failure” (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.

• MalfunctionApr 15, 2019Material Fragmentation; Material Fragmentation

  AS REPORTED TO CUSTOMER RELATIONS "THE VERY TIP OF THE DEPLOYMENT SYSTEM DETACHED FROM THE REMAINDER OF THE DEVICE. IT DID NOT BREAK BUT IT SOMEHOW DISASSEMBLED. IT CAME OUT OVER THE WIRE WITH THE REST OF THE DEVICE. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION."

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8514332 ↗
• MalfunctionJul 17, 2017Delivery System Failure; Delivery System Failure

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE ACTUAL BLACK COVERING OF THE ZILVER RELEASED FROM THE WHITE HUB, THE STENT WAS DEPLOYED WITH SOME DIFFICULTY AS THIS OCCURRED MID DEPLOYMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6717012 ↗