Zilver 635 G36239Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002362397), received between Apr 11, 2017 and Oct 14, 2024 — 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 14, 2024Off-Label Use; Off-Label Use

  DEVICE TRACKING FORM RECEIVED FROM CINC REGULATORY INDICATING PATIENT IS DECEASED. PROCEDURE INDICATES TO HAVE DM CONTACT PHYSICIAN TO CONFIRM IF THE DEVICE CAUSED/CONTRIBUTED TO THE DEATH. THE PHYSICIAN INDICATED: THE PATIENT HAD A TYPE A DISSECTION COMPLICATED BY MESENTERIC, RENAL AND PERIPHERAL ARTERIAL MALPERFUSION I DID A TEVAR, DISSECTION STENT AND LEFT RENAL ARTERY STENT CT SURGERY DELAYED FIXING THE TYPE DISSECTION BECAUSE THE PATIENT WAS STILL ON ANTICOAGULANTS WE FEEL SHE RETROGRADE, DISSECTED, EVEN MORE RUPTURED THEY HAD NOTHING TO DO WITH THE STENT PER SE. PATIENT OUTCOME: PATIENT EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438354 ↗
• MalfunctionApr 11, 2017Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE USER ADVANCED THE DELIVERY SHEATH INTO BODY WITH STENT AND IT WAS A CALCIFIED BIFURCATION. NO TROUBLE ADVANCING SYSTEM INTO THE BODY. THEY PULLED THE RED SAFETY AND BEGAN TO PIN AND PULL THE STENT DEPLOYMENT SYSTEM. THERE WAS EXTREME RESISTANCE WHEN TRYING TO PULL BACK ON THE SYSTEM. THEY PULLED HARD ENOUGH AND THE HUB SNAPPED BACK AND THE STENT DID NOT DEPLOY. THEY TOOK THE DEPLOYMENT SYSTEM OUT OF THE BODY. THEY BELIEVED THE STENT EITHER GOT STUCK ON SHEATH OR WHEN TAKING OFF THE RED SAFETY, THE SAFETY MAY NOT HAVE UNLOCKED. THE PHYSICIAN CONSIDERED THE CASE DONE AND THE PATIENT DID NOT RECEIVE THE STENT. THE DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED IN THE LAB. THE ENGINEERS DETERMINED THAT THE FAILURE MODE WAS: "HANDLE/FLEXOR SEPARATION". EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'FLEXOR BREAKAGE DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6481038 ↗