iCAST 85415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862854152), received between May 12, 2016 and Feb 4, 2021 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2021Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283236 ↗
• InjuryAug 21, 2020Expiration Date Error

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A STENT THAT HAD EXPIRED THE DAY BEFORE. THE PRODUCT WAS OWNED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440427 ↗
• MalfunctionFeb 25, 2020Inflation Problem

  DURING A COMPLICATED AAA CASE WHILE USING TWO 7X59 STENTS ONE OF THE BALLOONS ONLY OPENED AT THE DISTAL END. AFTER MULTIPLE ATTEMPTS TO EXPAND BALLOON THE DOCTOR WAS ABLE TO RELEASE THE BALLOON AND REMOVE IT FROM THE PARTIALLY DEPLOYED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752469 ↗
• InjurySep 11, 2019Device Slipped; Detachment of Device or Device Component

  N/A.

  Patient problems: Blood Loss; Occlusion

  MAUDE report 8994686 ↗
• InjuryNov 18, 2016Burst Container or Vessel

  THE PHYSICIAN INFLATED THE BALLOON TO DEPLOY THE STENT IN THE RENAL ARTERY. THEN DECIDED TO INFLATE THE BALLOON AGAIN. ON THE SECOND INFLATION THE BALLOON BURST. THE PATIENT IS FINE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6112061 ↗
• InjuryNov 18, 2016Burst Container or Vessel

  THE PHYSICIAN INFLATED THE BALLOON TO DEPLOY THE STENT IN THE RENAL ARTERY. THEN DECIDED TO INFLATE THE BALLOON AGAIN. ON THE SECOND INFLATION THE BALLOON BURST. THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6112052 ↗
• InjuryMay 31, 2016Detachment Of Device Component

  IT WAS REPORTED THAT A STENT CAME OFF OF THE BALLOON UPON ATTEMPTING IMPLANT. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5688898 ↗
• InjuryMay 12, 2016Detachment Of Device Component

  REPORT STATED THAT A STENT WAS INSERTED BY THE PHYSICIAN. BEFORE THE STENT WAS IN POSITION, THE PHYSICIAN NOTED THE STENT HAD MOVED OFF THE BALLOON. THE SYSTEM WAS REMOVED WITH THE STENT INTACT. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5650628 ↗

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