iCAST 85441Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 5MMX22MMX80CM · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00650862854411), received between May 31, 2016 and Sep 16, 2020 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Component Falling” (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
Device problems
- Component Falling1
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Hole In Material1
- Loose or Intermittent Connection1
Patient problems
- No Consequences Or Impact To Patient2
- No Information2
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2020Loose or Intermittent Connection; Failure to Advance
THE ICAST STENT THAT WOULD NOT CROSS THE LESION WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10544504 ↗MalfunctionOct 20, 2017Hole In Material
USED PRODUCT RETURNED WITH PIN HOLE IN BALLOON.
Patient problems: No Information
MAUDE report 6964297 ↗MalfunctionSep 6, 2017Detachment Of Device Component; Component Falling
MEDWATCH RECEIVED FROM FDA. THE STENT ON THE DELIVERY CATHETER FELL OFF OR SLIPPED OFF THE BALLOON AFTER THE DEVICE WAS OPENED ONTO THE STERILE FIELD. THIS OCCURRED PRIOR TO TRYING TO IMPLANT THE DEVICE IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 6844419 ↗InjuryMay 31, 2016Device Dislodged or Dislocated
DURING AN INTERVENTION ON AN ILIAC STENOSIS THE STENT BECAME DISLODGED FROM THE BALLOON IN THE SHEATH.
Patient problems: No Information
MAUDE report 5688928 ↗
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.