iCAST 85455Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00650862854558), received between Apr 14, 2016 and Jun 7, 2024 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Fracture; Activation Failure; Fracture; Activation Failure

  DURING THE PROCEDURE THE STENT BROKE WHILE BEING DEPLOYED, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489965 ↗
• MalfunctionMar 8, 2023Activation Failure; Activation Failure

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505352 ↗
• MalfunctionOct 17, 2022Detachment of Device or Device Component

  HOSPITAL STATES, "WE DID A CASE WITH DR. KIMBALL ON TUESDAY AND THE STENT FELL OF THE WIRE AS THEY WERE PUTTING IT IN THE PATIENT". THERE WAS NO HARM TO THE PATIENT AND ANOTHER STENT WAS USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614635 ↗
• MalfunctionJan 14, 2021Difficult to Advance; Material Deformation; Difficult to Advance

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11175549 ↗
• InjuryDec 9, 2016Collapse; Migration or Expulsion of Device

  HOME PATIENT CALLED TO REPORT ADVERSE EVENTS THAT OCCURRED AFTER PLACEMENT OF AN ICAST STENT IN HER LEFT COMMON CAROTID ARTERY. FOLLOW UP COMPUTED TOMOGRAPHY SCAN SHOWED MIGRATION OF THE GRAFT WITH PARTIAL COLLAPSE OF THE STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6157579 ↗
• InjuryNov 18, 2016Difficult to Insert; Device Operates Differently Than Expected

  THE PHYSICIAN WAS ATTEMPTING TO PLACE THE STENT BUT COULD NOT PASS THE STENT THROUGH THE LESION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6112058 ↗
• InjuryNov 9, 2016Detachment Of Device Component

  IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOOM ONCE IT WAS INSIDE THE HEMOSTATIC VALVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088746 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS THE PHYSICIAN WAS PREPARING TO DEPLOY THE STENT HE NOTICED BLOOD WAS COMING OUT OF THE BALLOON INFLATION PORT.

  Patient problems: Blood Loss

  MAUDE report 6041682 ↗
• InjuryMay 11, 2016Device Dislodged or Dislocated

  DURING AN INTERVENTION A STENT DISLODGED FROM THE BALLOON INSIDE OF A SHEATH.

  Patient problems: No Information

  MAUDE report 5647951 ↗
• InjuryMay 11, 2016Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT THE DOCTOR ADVANCED A STENT THROUGH A 7FR ANSEL SHEATH. THE PHYSICIAN THOUGHT THE DIAPHRAGM OF THE SHEATH CAUSED THE STENT TO COME OFF THE BALLOON. HE ADVANCED THE DELIVERY CATHETER TO THE TARGET AND SAW THAT IT WAS NOT LINED UP BETWEEN THE MARKER BANDS. HE REMOVED THE DEVICE COMPLETELY AND FOUND THAT THE STENT WAS NO LONGER MOUNTED ON THE BALLOON. IT WAS LOCATED IN THE SHEATH. THE ENTIRE SYSTEM WAS REMOVED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5647943 ↗
• InjuryApr 14, 2016Malposition of Device

  DURING AN INTERVENTION ON A RENAL ARTERY, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT BETWEEN THE MARKERS. HE WAS ABLE TO REMOVE THE STENT. NO HARM CAME TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5579480 ↗

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