iCAST 85414Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00650862854145), received between May 31, 2016 and Oct 4, 2022 — classified as 8 injuries, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2022Difficult to Remove; Material Separation; Separation Failure; Difficult to Remove; Separation Failure

  DURING A PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT (PMEG) PROCEDURE CASE AND AFTER DEPLOYING THE ICAST STENT IN THE CELIAC ARTERY THE CATHETER SEPARATED COMPLETELY APPROXIMATELY 4CM FROM THE PROXIMAL MARKER ON THE BALLOON LEAVING THE BALLOON PORTION AND PART OF THE CATHETER REMAINING IN THE CELIAC ARTERY. THE DOCTOR THEN USED A SNARE AND WAS ABLE TO RETRIEVE THE REMAINING CATHETER AND BALLOON SYSTEM. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539958 ↗
• InjuryFeb 24, 2020Expiration Date Error

  REPORT RECEIVED STATED THAT A PHYSICIAN IMPLANTED AN ICAST STENT IN A PATIENT THAT THE STENTS EXPIRATION DATE HAD EXPIRED. THE STENT WAS IMPLANTED IN THE SUBCLAVIAN AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744028 ↗
• InjuryAug 16, 2019Obstruction of Flow

  N/A

  Patient problems: Occlusion

  MAUDE report 8900241 ↗
• MalfunctionMay 14, 2019Migration; Migration

  TECH NOTICED STENT WAS LOOSE AND NOT ON THE BALLOON, SO THEY DID NOT PUT IT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609573 ↗
• MalfunctionFeb 7, 2019Activation, Positioning or Separation Problem

  N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319017 ↗
• InjuryNov 8, 2017Device Dislodged or Dislocated

  IT WAS REPORTED DURING A PHYSICIAN MODIFIED ABDOMINAL AORTIC ANEURYSM (AAA) GRAFT CASE STENT WAS PLACED IN THE RIGHT RENAL ARTERY. ON BALLOON INFLATION THE PHYSICIAN NOTICED THAT THE STENT WAS NOT PRESENT ON THE BALLOON. ANOTHER STENT WAS USED AND SUCCESSFULLY DEPLOYED INTO INTENDED TARGET SITE. THE MISSING STENT WAS FOUND DISLODGED IN THE SHEATH AND WAS REMOVED. PATIENT HAD NO NEGATIVE EFFECTS OF THIS EVENT.

  Patient problems: Aneurysm

  MAUDE report 7010477 ↗
• InjurySep 12, 2017Break

  IT WAS REPORTED THAT THE PHYSICIAN DELIVERED THE STENT TO THE TARGET AND DETERMINED IT WAS TOO LONG. HE REMOVED THE STENT SUCCESSFULLY AND COMMENTED THAT THE HUB WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6859310 ↗
• InjuryOct 10, 2016Difficult or Delayed Positioning

  THE STENT COULD NOT BE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6013520 ↗
• InjurySep 23, 2016Mechanical Jam

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO STENT AN ILIAC ARTERY VIA A BRACHIAL APPROACH THROUGH A 7 FR ARROW SHEATH. AS THE DOCTOR WAS RETRACTING THE BALLOON THROUGH THE SHEATH, THE BALLOON GOT STUCK ON THE TAPERED END OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5973627 ↗
• InjuryMay 31, 2016Burst Container or Vessel; Inflation Problem; Pressure Problem

  THE PHYSICIAN WAS USING THE STENT IN A KISSING STENT PROCEDURE TO TREAT BILATERAL COMMON ILIAC DISEASE. AFTER CROSSING EACH LESION THE STENT WAS POSITION AND THE SHEATH WITHDRAWN. THE LEFT STENT DID NOT INFLATE. THE BALLOON WOULD NOT HOLD PRESSURE. BLOOD WAS VISIBLE IN THE INSUFFLATOR INDICATING THAT THE BALLOON HAD BURST.

  Patient problems: No Information

  MAUDE report 5688893 ↗

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