iCAST 85408Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862854084), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS PART OF THE ZENITH® P-BRANCH® PIVOTAL STUDY BEING CONDUCTED BY COOK, INC., THE FOLLOWING EVENT WAS NOTED: EVENT: ON (B)(6) 2021 (1865 DAYS POST-PROCEDURE), THE 5-YEAR CT SCAN WAS PERFORMED. SITE ANALYSIS NOTED DEVICES HAD NO EVIDENCE OF SEPARATION OF COMPONENTS, OR DEVICE INTEGRITY ISSUES. THE SMA (WITHIN THE STENT) WAS NOT PATENT. CORE LAB ANALYSIS OF THE CT SCAN NOTED DEVICES HAD NO EVIDENCE OF SEPARATION OF COMPONENTS OR DEVICE INTEGRITY ISSUES. CORE LAB NOTED THAT THE SMA STENT GRAFT WAS OCCLUDED PROXIMALLY. CORE LAB ALSO NOTED THAT THE P-BRANCH DEVICE MIGRATED CAUDALLY. CORE LAB STATED, ¿RIGHT RENAL STENT GRAFT APPEARS TO HAVE SIGNIFICANT IN-STENT STENOSIS, BUT UNABLE TO ASSESS DEGREE DUE TO LARGE SLICE THICKNESS OF CT SCAN. ALSO NOTED DOWNWARD MIGRATION OF P-BRANCH COMPONENT ABOUT 11MM FORCING COMPRESSION AND PROXIMAL OCCLUSION OF SMA STENT GRAFT.¿ ON (B)(6) 2021 (1875 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION (SI) WAS PERFORMED. CLINICAL SIGNS AND SYMPTOMS WERE DIARRHEA AND ABDOMINAL CRAMPING. A BALLOON ANGIOPLASTY WAS PERFORMED, AND A STENT WAS PLACED. THE SI WAS SUCCESSFUL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12037433 ↗

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