iCAST 85450Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 5MMX16MMX120CM · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00650862854503), received between May 31, 2016 and Jan 29, 2024 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Failure to Advance2
- Activation, Positioning or Separation Problem1
- Difficult to Advance1
- Difficult to Remove1
Patient problems
- No Information2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MalfunctionMar 5, 2020Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE STENT WOULD NOT PASS THROUGH THE LESION AS THE TIP OF THE CATHETER KEPT GETTING CAUGHT ON THE STENOSIS. WHEN ATTEMPTING TO RETRIEVE THE STENT BACK INTO THE SHEATH IT BECAME DISLODGED IN THE VALVE OF THE SHEATH AND WAS NOT RECOVERED.
Patient problems: No Information
MAUDE report 9796078 ↗MalfunctionAug 28, 2017Failure to Advance
IT WAS REPORTED THAT THE STENT WOULD NOT CROSS THE OCCLUSIVE LESION IN THE ILIAC ARTERY.
Patient problems: No Information
MAUDE report 6823609 ↗InjuryFeb 27, 2017Device Dislodged or Dislocated
THE STENT ADVANCED THROUGH THE HEMOSTATIC VALVE OF THE INTRODUCER AND CAME OFF THE BALLOON AS IT ENTERED A COOK 6FR SHEATH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6361157 ↗InjuryFeb 27, 2017Device Dislodged or Dislocated
THE STENT ADVANCED THROUGH THE HEMOSTATIC VALVE OF THE INTRODUCER AND CAME OFF THE BALLOON AS IT ENTERED A COOK 6FR SHEATH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6361150 ↗InjuryMay 31, 2016Failure to Advance
IT WAS REPORTED THAT THE STENT WOULD NOT ADVANCE THROUGH THE SHEATH. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5688902 ↗
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.