Zilver 635 G43821Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002438214), received between Nov 10, 2020 and Aug 18, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionAug 18, 2023Off-Label Use; Off-Label Use

  ON (B)(6) 2023 AT THE (B)(6), ONE OF OUR CLINICIANS EXPERIENCED A DEVICE MALFUNCTION DURING DEPLOYMENT. NO PATIENT HARM OCCURRED, ACCORDING TO THE PHYSICIAN. WE ARE CONDUCTING AN INTERNAL INVESTIGATION INTO THIS INCIDENT AND CAN RETURN THE ITEM IN QUESTION UPON COMPLETION FOR YOUR CORROBORATING INVESTIGATION. I NOTICED THERE WAS A RECALL FOR THESE ITEMS IN APRIL 2013, BUT NO ACTIVE RECALLS FOR THIS ITERATION OF THE ITEM. PLEASE LET US KNOW IF YOU REQUIRE ANY ADDITIONAL INFORMATION, OR IF WE NEED TO COMPLETE ANY DOCUMENTATION. PER EMAIL ON 25JUL2023: DURING A LOWER EXTREMITY ANGIOGRAM, WE POSITIONED A STENT ACROSS A LESION AND DEPLOYED IT. WHEN WE WENT TO REMOVE THE DEPLOYMENT DEVICE, WE NOTED THE STENT MOVED WITH IT AND WAS NOT COMPLETELY DEPLOYED. WE IDENTIFIED THAT THE OUTER SHEATH THAT CONSTRAINS THE STENT AND IS SUPPOSED TO ROLL BACK WITH THE DEPLOYMENT HANDLE HAD SEPARATED FROM THE HANDLE, AND THE STENT WAS STILL CONSTRAINED. WE MANUALLY PULLED THE SHEATH BACK WITH A HEMOSTAT TO RELEASE THE STENT. WE THEN REMOVED THE ENTIRE DEPLOYMENT DEVICE OUT OF THE PATIENT. THE STENT REMAINED IN THE PATIENT, AS IT SHOULD. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 25JUL2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570947 ↗
• MalfunctionNov 10, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10820545 ↗