iCAST 85443Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00650862854435), received between Aug 15, 2016 and Oct 9, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Material Rupture; Activation Failure; Material Rupture; Activation Failure

  DURING THE PROCEDURE FOR FENESTRATED ENDOGRAPH, AN ICAST STENT WAS SELECTED AND DEEMED DEFECTIVE AS THE BALLOON POPPED UPON INFLATION TO EXPAND THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895505 ↗
• MalfunctionSep 25, 2021Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use

  VASCULAR SURGEON STATED THAT WHEN THE CATHETER DELIVERY SYSTEM HAD A KINK IN THE SHAFT JUST BELOW THE BALLOON. STENT WAS DEPLOYED HOWEVER IT WAS DIFFICULT TO INFLATE AND DEFLATE BALLOON DUE TO THE KINK IN CATHETER DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530835 ↗
• MalfunctionDec 10, 2019Inflation Problem

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9445971 ↗
• MalfunctionAug 13, 2019Loose or Intermittent Connection

  N/A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889369 ↗
• MalfunctionJun 19, 2019Difficult to Insert

  AS PART OF (B)(6) STUDY BEING CONDUCTED BY COOK, INC., THE FOLLOWING EVENT WAS NOTED: ON (B)(6) 2018, THE SITE REPORTED DIFFICULTY INSERTING THE ABOVE DEVICE INTO THE RIGHT RENAL ARTERY. FROM THE OPERATIVE NOTE: ¿MULTIPLE ATTEMPTS WERE MADE TO CANNULATE THE RIGHT RENAL ARTERY. THE WIRE WOULD PASS INTO THE VESSEL, BUT THE CATHETER COULD NOT BE PASSED OUT INTO THE DISTAL VESSELS FOLLOWED BY A STIFF WIRE.¿ IN THE END, THE STENT WAS SUCCESSFULLY DEPLOYED INTO THE RIGHT RENAL ARTERY. THE PATIENT WAS DISCHARGED 5 DAYS POST-PROCEDURE AND NO ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Information

  MAUDE report 8714775 ↗
• MalfunctionJan 25, 2019Entrapment of Device; Activation, Positioning or Separation Problem; Device Fell

  IT WAS REPORTED THAT THE ICAST WAS ATTEMPTED TO BE USED IN A RENAL ARTERY. THERE WAS A PREVIOUSLY PLACED SELF EXPANDING BARE METAL STENT THAT THE PHYSICIAN WAS TRYING TO RE LINE. THE ICAST APPEARS TO HAVE BEEN CAUGHT ON THE EDGE OF BARE METAL STENT AND COMPROMISED. THE ICAST WAS NOT DEPLOYED AND WHEN COMING BACK OUT OF THE 6F ANSEL SHEATH THE STENT FELL OFF THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280182 ↗
• MalfunctionAug 15, 2016Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE HAD BEEN OPENED AND FLUSHED. THEY TRIED TO PLACE A WIRE THROUGH THE LUMEN BUT NOTHING WOULD GO THROUGH. THE PRODUCT WAS NEVER USED AS THEY COULD NOT LOAD IT ON THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5876478 ↗

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