iCAST 85451Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862854510), received between May 10, 2016 and Oct 1, 2021 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryOct 1, 2021Device-Device Incompatibility; Leak/Splash; Device-Device Incompatibility

  REPORT RECEIVED STATED ON 31JUL2017, THE POST PROCEDURE COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED. SITE ANALYSIS NOTED THAT THE DEVICES WERE PATENT WITH NO EVIDENCE OF SEPARATION OF COMPONENTS, OR DEVICE INTEGRITY ISSUES. A TYPE II ENDOLEAK WAS NOTED. CORE LAB ANALYSIS OF THE CT SCAN NOTED PATENT DEVICES WITH NO EVIDENCE OF SEPARATION OF COMPONENTS OR DEVICE INTEGRITY ISSUES. A TYPE III ENDOLEAK WAS NOTED AT THE P-BRANCH AND THE RIGHT RENAL STENT. ON (B)(6) 2018, THE SIX-MONTH FOLLOW-UP CT SCAN AND ULTRASOUND WERE PERFORMED. SITE ANALYSIS NOTED THAT THE DEVICES WERE PATENT WITH NO EVIDENCE OF MIGRATION, SEPARATION OF COMPONENTS, OR DEVICE INTEGRITY ISSUES. A TYPE II ENDOLEAK WAS NOTED. CORE LAB ANALYSIS OF THE CT SCAN NOTED PATENT DEVICES WITH NO EVIDENCE OF MIGRATION, SEPARATION OF COMPONENTS, OR DEVICE INTEGRITY ISSUES. AN UNKNOWN TYPE ENDOLEAK WAS NOTED. CORE LAB NOTED, ¿UNSURE ORIGIN OF ENDOLEAK.¿ CORE LAB EVALUATION OF THE ULTRASOUND NOTED PATENT VESSELS WITH AN UNKNOWN TYPE ENDOLEAK. COMMENTS FROM CORE LAB NOTED ¿ENDOLEAK ON TWO CINE LOOPS: ONE SUGGESTS FROM THE GRAFT ITSELF (TYPE IV) (DISTAL PART OF THE FENESTRATED COMPONENT) WHILE ANOTHER SUGGESTS FROM THE IMA (TYPE I

  Patient problems: Aneurysm; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12565724 ↗
• InjuryAug 30, 2021Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility

  N/A.

  Patient problems: Aneurysm; Calcium Deposits/Calcification

  MAUDE report 12383868 ↗
• MalfunctionMar 21, 2021Material Rupture; Material Rupture

  REPORT RECEIVED STATED THAT A 4 MM VESSEL THAT WAS POSTERIOR DOWN FACING. SLOWLY INFLATED 5X22X120 ICAST AND DEFLATED ICAST. REINFLATED ICAST AND THE BALLOON POPPED AND INVERTED ON ITSELF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536813 ↗
• MalfunctionDec 22, 2020Break

  IT WAS REPORTED THAT DURING A PROCEDURE OF RENAL STENT PLACEMENT, THE SURGEON NOTICED THE STENT WAS RIPPED SO HE TOOK IT OUT.

  Patient problems: No Information

  MAUDE report 11061317 ↗
• MalfunctionJul 2, 2019Burst Container or Vessel

  N/A.

  Patient problems: No Information

  MAUDE report 8752753 ↗
• InjuryDec 22, 2016Detachment Of Device Component

  AS THE PHYSICIAN WAS PUSHING THE STENT OVER THE WIRE THE STENT CAME LOOSE AND WAS OFF THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6197804 ↗
• InjurySep 23, 2016Device Slipped

  THE DEVICE WAS PLACED INTO A 6FR ANSEL SHEATH HUB AND THE STENT SLIPPED BACK ONTO THE BALLOON CATHETER BEFORE IT COULD BE PLACED IN THE PATIENT. THE PATIENT WASN'T HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5973725 ↗
• InjuryMay 10, 2016Component Falling

  THE PROCEDURE WAS AN INTERVENTION ON A RENAL ARTERY. IT WAS REPORTED THAT THE STENT FELL OFF PRIOR TO INFLATING THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5644761 ↗

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