Zilver 635 G43856Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002438566), received between Sep 10, 2018 and Oct 1, 2019 — 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 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.

• MalfunctionOct 1, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  [17/SEP/2019 SHOHEI KON ADDED ADDITONAL INFORMATION ]. IPSILATERAL APPROACH WAS GAINED FROM THE FEMORAL ARERY. THE USER DEPLOYED THE STENT (ZIV6-35-80-8-40/ C1527776) BUT THE STENT WAS NOT FULLY EXPANDED (STENT DIAMETER WAS SMALLER THAN 8MM). POST-DILATION WAS PERFORMED WITH TERUMO'S SENRI 8MM BALLOON BUT THE STENT WAS STILL NOT FULLY EXPANDED. THEREFORE, ANOTHER STENT(8MM X 40MM) WAS PLACED INSIDE THE COMPLAINED STENT AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT SHORTENING/COMPRESSION DURING DEPLOYMENT¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141821 ↗
• MalfunctionSep 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  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 (B)(6) 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 7860201 ↗