iCAST 85444Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 7MMX16MMX80CM · Class 2 · Implant
All models of iCAST (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00650862854442), received between Sep 13, 2017 and Dec 14, 2021 — classified as 1 injury, 6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
- Detachment Of Device Component2
- Difficult to Open or Close2
- Detachment of Device or Device Component1
Patient problems
- No Information3
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionAug 20, 2019Activation, Positioning or Separation Problem
MalfunctionAug 20, 2019Activation, Positioning or Separation Problem
MalfunctionAug 24, 2018Difficult to Open or Close
MalfunctionAug 24, 2018Difficult to Open or Close
STENT WAS ATTEMPTED TO BE DEPLOYED BUT BALLOON WOULD NOT OPEN.
Patient problems: No Information
MAUDE report 7814356 ↗MalfunctionOct 10, 2017Detachment Of Device Component
THE STENT CAME OFF OF BALLOON AFTER INSERTED INTO PT. STENT AND BALLOON WERE RETRIEVED AND RETURNED TO STERILE FIELD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6935532 ↗InjurySep 13, 2017Detachment Of Device Component
THE PROCEDURE WAS A PERCUTANEOUS 4 VESSEL FENESTRATED ENDOVASCULAR AORTIC ANEURYSM REPAIR. THE STENT CAME OFF THE BALLOON AFTER INSERTION INTO PATIENT. STENT AND BALLOON BOTH WERE RETRIEVED SUCCESSFULLY AND RETURNED TO THE STERILE FIELD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6861003 ↗
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
- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
- iCAST 85455Atrium Medical Corporation · Prosthesis, tracheal, expandable11 reports
- iCAST 85414Atrium Medical Corporation · Prosthesis, tracheal, expandable10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page