iCAST 85418Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00650862854183), received between May 31, 2016 and Feb 28, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Material Rupture

  REPORT RECEIVED STATED DURING A PROCEDURE FOR AN ILLIAC OCCLUSION, WITH SHOCKWAVE USED PRIOR FOR PRE-DILATION. THE ICAST WAS INSERTED AFTERWARDS ALONG WITH ANOTHER BALLOON ON THE CONTRA SIDE. BOTH WERE EXPANDED TOGETHER. ICAST BALLOON RUPTURED BEFORE GETTING TO ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619638 ↗
• MalfunctionOct 5, 2021Premature Activation; Premature Separation; Premature Activation; Activation, Positioning or Separation Problem; Premature Separation

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 12579440 ↗
• MalfunctionAug 11, 2020Material Split, Cut or Torn

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394340 ↗
• InjuryMay 18, 2017Inflation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS A THORACIC AORTIC ANEURYSM VASCULAR REPAIR (TAVR). THE PHYSICIAN PLANNED TO STENT THE LEFT COMMON FEMORAL ARTERY FROM A RIGHT GROIN APPROACH USING A 25 CM 7FR BOSTON SCIENTIFIC SHEATH. THE STENT WAS PLACED AND ON INFLATION OF THE BALLOON BLOOD WAS SEEN IN THE INSUFFLATOR. ONLY THE DISTAL END OF THE STENT BALLOON DEPLOYED. WHEN REMOVING THE BALLOON THE STENT MOVED BACK TO THE LEVEL OF THE COMMON ILIAC ARTERY. AFTER MULTIPLE INFLATION ATTEMPTS THE BALLOON WAS REMOVED AND THE STENT WAS DEPLOYED IN THE LEFT ILIAC. AN ADDITIONAL STENT WAS THEN SUCCESSFULLY PLACED IN THE LEFT COMMON FEMORAL ARTERY. THE PATIENT IS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6575745 ↗
• InjuryJun 28, 2016Deflation Problem

  IT WAS REPORTED THAT AFTER DEPLOYING THE STENT THE BALLOON DID NOT DEFLATE AS EXPECTED. THE BALLOON TOOK TOO LONG TO DEFLATE.

  Patient problems: No Information

  MAUDE report 5754837 ↗
• InjuryMay 31, 2016Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE STENT IN THE ILIAC ARTERY, THE BALLOON GOT CAUGHT ON A CALCIUM DEPOSIT AND RUPTURED. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5688922 ↗

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