iCAST 85404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862854046), received between Sep 6, 2022 and Oct 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STENT HAS SNAPPED OFF WITHIN THE SHEATH, ENTIRE SHEATH WAS REMOVED AND UPON INSPECTION SAW THAT BALLOON SNAPPED OFF THE SHAFT PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895511 ↗
• MalfunctionSep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A FENESTRATED EVAR CASE, PHYSICIAN ATTEMPTED TO DELIVER A 7X38X80CM ICAST STENT THROUGH A MEDTRONIC APTUS 7F STEERABLE SHEATH THROUGH A FENESTRATION IN THE ENDOGRAFT AND INTO THE CELIAC ARTERY. DUE TO INSUFFICIENT SHEATH BACKUP SUPPORT, THE STENT WAS UNABLE TO BE ADVANCED INTO THE ARTERY, SO THE PHYSICIAN PLANNED TO REMOVE THE ICAST AND REPLACE IT WITH A BALLOON CATHETER TO USE IT TO HELP PULL THE SHEATH THROUGH THE FENESTRATION FOR BETTER SHEATH BACKUP SUPPORT. HOWEVER, UPON REMOVING THE ICAST FROM THE PATIENT, THE STENT BECAME PARTIALLY DISLODGED FROM THE DELIVERY BALLOON AS IT PASSED THROUGH THE RUBBER VALVE OF THE APTUS SHEATH. THE STENT REMAINED ON THE BALLOON BUT IN A SHIFTED POSITION AND IT WAS PUT ASIDE. NOTHING FROM THAT ORIGINAL DEVICE WAS RETAINED IN THE PATIENT. PHYSICIAN SUCCESSFULLY IMPLANTED A DIFFERENT ICAST IN THE CELIAC ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362327 ↗

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