Zilver 635 G36246Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002362465), received between Mar 30, 2016 and Jan 4, 2018 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  AS REPORTED TO CUSTOMER RELATIONS: " WHILE PREPPING THE DEVICE FOR AN UNKNOWN PROCEDURE IT WAS NOTED THAT THE DELIVERY SYSTEM WAS BENT. THE DEVICE WAS PUT ASIDE AND ANOTHER OF THE SAME WAS PULLED FROM THEIR SHELF AND USED TO DO THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163736 ↗
• InjuryMay 3, 2017Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  PATIENT UNDERWENT ELECTIVE STENT PROCEDURE OF LEFT ILIAC VEIN ON (B)(6) 2017. PATIENT RETURNED TO THE ER ON (B)(6) 2017 WITH COMPLAINT OF CHEST PAIN AND SHORTNESS OF BREATH, CT SCAN OF CHEST REVEALED A VENOUS STENT IN THE RIGHT VENTRICLE AND A VASCULAR COIL IN RIGHT PULMONARY ARTERY; PATIENT TO IR FOR RETRIEVAL OF FOREIGN BODY. PATIENT REQUIRED OPEN HEART SURGERY TO REMOVE REST OF FOREIGN BODY IN THE RIGHT ATRIUM. OPEN ATRIOTOMY ON (B)(6) 2017: REMOVAL OF THE METALLIC STENT PIECES ATTACHED TO THE CHORDAE TENDINAE AND UNDER SIDE OF THE SIGNAL BRANCH OF THE MITRAL VALVE INSIDE THE RIGHT VENTRICLE. UPDATE - SPOKE WITH RISK MANAGER - SHE CONFIRMED THAT THE COIL REFERENCED IN THE MEDWATCH REPORT IS A TERUMO AZUR COIL. SHE ALSO CONFIRMED THAT THERE WERE TWO INTERVENTION PROCEDURES. ONE IN IR ON (B)(6) 2017 WHERE "A BUNCH" OF STENT FRAGMENTS WERE RETRIEVED AND ANOTHER ON (B)(6) 2017 WHERE THE FINAL TWO FRAGMENTS WERE RETRIEVED DURING AN OPEN ATRIOTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6539743 ↗
• MalfunctionMar 30, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE ZILVER BILIARY STENT DEPLOYED PREMATURELY WITH THE SAFETY LOCK STILL ON. THE DELIVERY SYSTEM WAS STUCK ON THE WIRE. WHEN THEY PULLED THE DELIVERY SYSTEM BACK, THE STENT GOT CAUGHT ON THE SHEATH. THEY HAD THE DELIVERY SYSTEM COMPLETELY REMOVED FROM THE PATIENT. DURING THAT TIME, THE STENT PREMATURELY DEPLOYED IN THE WRONG PART OF THE PATIENT'S ANATOMY. IT WAS SHORTENED/CRIMPED/CRUNCHED. IT DEPLOYED IN THE COMMON FEMORAL VEIN BUT WAS MEANT TO BE DEPLOYED IN THE ILIAC VEIN. THEY COMPLETED THE PROCEDURE WITH ANOTHER STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5534076 ↗