iCAST 85406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00650862854060), received between Jul 27, 2016 and Sep 6, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K050814); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 6, 2017Burst Container or Vessel

  THE PHYSICIAN USED A STENT FOR A RIGHT COMMON ILIAC ARTERY TARGET IN A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR. THE VASCULATURE WAS HEAVILY CALCIFIED. THE STENT DEPLOYED CORRECTLY BUT THE BALLOON BURST AT 10 ATM.

  Patient problems: No Information

  MAUDE report 6844408 ↗
• InjuryAug 23, 2016Fitting Problem

  IT WAS REPORTED THAT A STENT WAS SUCCESSFULLY PLACED IN THE LEFT COMMON ILIAC ARTERY. WHEN THE PHYSICIAN WENT TO REMOVE THE BALLOON IT WOULD NOT FIT BACK INTO THE SHEATH. THE SHEATH AND BALLOON HAD TO BE REMOVED AT THE SAME TIME. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5897420 ↗
• InjuryJul 27, 2016Insufficient Flow or Under Infusion

  AS PART OF THE PRESERVE-ZENITH ILIAC BRANCH CLINICAL STUDY BEING CONDUCTED BY COOK, INC., THE FOLLOWING EVENT WAS NOTED: IT WAS REPORTED THAT ON THE 12-MONTH FOLLOW-UP COMPUTED TOMOGRAPHY SCAN, THE STENT WAS NOTED TO BE OCCLUDED. THE FACILITY INDICATED THAT BOTH THE INTERNAL ILIAC ARM OF THE BRANCH GRAFT AND THE ICAST WERE INVOLVED. ACCORDING TO THE SITE - "POOR OUTFLOW/RUNOFF OF INTERNAL ILIAC ARTERY MOST LIKELY CAUSE".

  Patient problems: Occlusion

  MAUDE report 5825288 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050814. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2022 · Mar 3, 2022 · Open, Classified
  iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 8541
• Z-2761-2017 · May 25, 2017 · Terminated
  Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm