iCAST 85424Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 10MMX38MMX120CM · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00650862854244), received between Apr 14, 2016 and Feb 9, 2023 — classified as 4 injuries, 5 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
Device problems
- Activation, Positioning or Separation Problem2
- Break1
- Burst Container or Vessel1
- Component Falling1
- Deflation Problem1
- Detachment Of Device Component1
- Difficult to Insert1
- Insufficient Device Problem Information1
Patient problems
- No Information3
- No Consequences Or Impact To Patient2
- Foreign Body Embolism1
- Ischemia1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
InjurySep 20, 2022Separation Problem; Separation Problem
PHYSICIAN WAS TRYING TO POSITION THE STENT ON A BILATERAL REPAIR. IT APPEARS THAT THE LESION WAS CALCIFIC AND IT WAS A CHALLENGE TO POSITION. IT APPEARED THAT THE BALLOON AND STENT DISLODGED WHILE ABORTING THE POSITIONING ATTEMPT. FOLLOW UP WITH THE PHYSICIAN WILL BE NEEDED TO VERIFY.
Patient problems: Foreign Body Embolism
MAUDE report 15454924 ↗MalfunctionJan 31, 2021Break
MalfunctionAug 20, 2020Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE STENT, THE BALLOON GOT CAUGHT ON THE STENT AND REMAINED IN THE DOG-BONE POSITION. THE SURGEON WAS UNABLE TO DEPLOY THE STENT. IT WAS REMOVED AND A DIFFERENT PRODUCT WAS USED.
Patient problems: No Information
MAUDE report 10431828 ↗MalfunctionMay 6, 2019Burst Container or Vessel
MalfunctionAug 28, 2017Detachment Of Device Component; Component Falling
IT WAS REPORTED THE THE STENT BALLOON FELL OFF.
Patient problems: No Information
MAUDE report 6823630 ↗InjurySep 23, 2016Difficult to Insert; Malposition of Device
THE PROCEDURE WAS DONE FROM THE BRACHIAL ARTERY AND THE STENT WAS ATTEMPTED TO BE PLACED IN THE LEFT INTERNAL ILIAC. IT WAS PRETTY TORTUOUS AND THE PHYSICIAN REPORTED THAT A 10X38 STENT WOULD NOT PASS THROUGH A 7FR SHEATH.
Patient problems: No Information
MAUDE report 5973710 ↗InjuryJun 9, 2016Deflation Problem
THE STENT WAS SUCCESSFULLY DEPLOYED IN THE DISTAL AORTA THAT HAD GREATER THAN 50% STENOSIS. HOWEVER, THE BALLOON WOULD NOT DEFLATE AFTER 2 ATTEMPTS PULLING NEGATIVE PRESSURE FOR 10 SECONDS. THE ENTIRE SYSTEM HAD TO BE REMOVED. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5709480 ↗InjuryApr 14, 2016Insufficient Device Problem Information
THE PHYSICIAN WAS PLACING A STENT INTO THE BRACHIO-CEPHALIC ARTERY. THE STENT DEPLOYED WITHOUT DIFFICULTY AND BLOODFLOW WAS RESTORED. WHILE DEFLATING THE BALLOON THE PATIENT EXHIBITED SOME NEUROLOGICAL CHANGES AND ST SEGMENT ELEVATION THAT WAS TRANSIENT. THE SYMPTOMS RESOLVED COMPLETELY AND THE PATIENT WAS DISCHARGED AS PLANNED. THE PHYSICIAN STATED THAT THE PATIENT EXPERIENCED SOME TRANSIENT CEREBRAL ISCHEMIA RELATED TO PLAQUE IN HER CEREBRAL ARTERIES THAT RESOLVED.
Patient problems: Ischemia
MAUDE report 5577828 ↗
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, ClassifiediCast 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 · TerminatedAtrium 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
Other Prosthesis, tracheal, expandable devices
- iCAST 85453Atrium Medical Corporation · Prosthesis, tracheal, expandable43 reports
- WALLSTENT™ BILIARY H965430500Boston Scientific Corporation · Prosthesis, tracheal, expandable13 reports
- iCAST 85419Atrium Medical Corporation · Prosthesis, tracheal, expandable13 reports
- iCAST 85445Atrium Medical Corporation · Prosthesis, tracheal, expandable12 reports
- iCAST 85416Atrium Medical Corporation · Prosthesis, tracheal, expandable12 reports
- iCAST 85455Atrium Medical Corporation · Prosthesis, tracheal, expandable11 reports
- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
- iCAST 85414Atrium Medical Corporation · Prosthesis, tracheal, expandable10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.