Zilver 635 G43866Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002438665), received between Aug 4, 2017 and Sep 10, 2018 — 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 16, 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.

• MalfunctionSep 10, 2018Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available; Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO CUSTOMER RELATIONS: "DISCUSSION WITH STAFF NURSE SOUNDED LIKE THERE WAS STENT MIGRATION." ADDITIONAL INFORMATION PROVIDED BY DM ON 24AUG2018: "(B)(6) WILL FORWARD WHAT HE HAS. WE ARE TRYING TO GET IVUS PICS WITHOUT PHI AS WELL." REQUEST FORWARDED FROM DM ON BEHALF OF PHYSICIAN ON 24AUG2018: "ALSO, ON TOP OF THE STANDARD LETTER WHICH GETS SENT CAN WE HAVE SOMEONE CALL DR. (B)(6) TO DISCUSS IN FURTHER DETAIL. DR. (B)(6) WAS TRAINED AND HAS PRACTICED EXTENSIVELY WITH COOK PRODUCT. THIS CASE CERTAINLY SEEMS LIKE AN ANOMALY, AND ADDITIONAL FOLLOW UP WOULD BE VALUABLE FOR BOTH SIDES I BELIEVE. THANKS FOR ANY HELP YOU CAN OFFER WITH THIS FOLLOW UP."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7860256 ↗
• MalfunctionAug 4, 2017Delivery System Failure; Delivery System Failure

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION RELATING TO THIS EVENT AND RETURN OF THE COMPLAINT DEVICE. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: WHILE THE STENT WAS BEING DELIVERED, THERE WAS RESISTANCE PUSHING OVER THE WIRE. AFTER THE SYSTEM WOULD NOT TRACK OVER THE CEPHALIC ARCH, THE USER ATTEMPTED TO PULL BACK. WHILE ATTEMPTING TO REMOVE, THE FLEXOR MATERIAL SEPARATED FROM THE DELIVERY CATHETER AT THE HUB OF THE HANDLE. THE ENTIRE DEVICE WAS ABLE TO BE REMOVED BY HAND AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE (DIFFERENT SIZE) WAS USED TO COMPLETE THE PROCEDURE. THE STENT WAS NOT DEPLOYED, AT ALL, AT ANY TIME. ADDITIONAL INFORMATION RECEIVED ON 28-AUG-17: "IT WAS A VENOUS STENTING CASE, THEY WERE TRYING TO PLACE THE STENT AT THE CEPHALIC ARCH, AND WHEN THEY TRIED TO ADVANCE THE DELIVERY SYSTEM PAST THE ARCH BEFORE BRINGING IT BACK, THE SYSTEM BROKE. WHERE THE FLEXOR MATERIAL MEETS THE HANDLE IT CAME APART."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6766739 ↗