iCAST 85420Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 10MMX38MMX80CM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862854206), received between May 11, 2016 and May 5, 2021 — classified as 5 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture2
- Break1
- Burst Container or Vessel1
- Hole In Material1
- Insufficient Device Problem Information1
- Leak/Splash1
- Material Deformation1
- Separation Problem1
Patient problems
- No Information2
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Obstruction/Occlusion1
- Occlusion1
- Stenosis1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2021Material Rupture; Material Rupture
MalfunctionSep 3, 2020Stretched; Material Deformation
THE PHYSICIAN WAS DOING A STENTING BILATERAL TO THE PROXIMAL COMMON ILIAC ARTERIES. REPORT RECEIVED STATED THAT WHERE THE STENT AND BALLOON ATTACHED TO THE SHAFT, IT APPEARED STRETCHED OUT UPON REMOVAL AND THERE WAS CONCERN THE BALLOON COULD HAVE DETACHED IN PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE BALLOON WITH NO HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10492219 ↗InjuryNov 12, 2019Material Rupture; Separation Problem
DURING A BILATERAL ILIAC ARTERY ANGIOPLASTY AND STENTING PROCEDURE, THE BALLOON RUPTURED AND THEN SEPARATED FROM THE CATHETER.
Patient problems: Occlusion
MAUDE report 9310189 ↗InjuryAug 1, 2019Break
IT WAS REPORTED THAT THE PHYSICIAN PLACED THE STENT IN THE RIGHT COMMON ILIAC ARTERY. AFTER SUCCESSFULLY DEPLOYING THE STENT, WHEN REMOVING THE CATHETER FROM THE PATIENT, THE BALLOON SHEARED OFF THE CATHETER AND REMAINED ON THE WIRE AND PART OF THE BALLOON WAS IN THE SHEATH. THE CATHETER WHEN OFF THE WIRE, DIDN'T HAVE THE BALLOON ON IT. ACCESS WAS GAINED ON THE CONTRALATERAL SIDE AND A SNARE WAS ATTEMPTED TO CAPTURE THE BALLOON WHICH WAS UNSUCCESSFUL. THE PHYSICIAN REMOVED THE 7 FR SHEATH AND THE BALLOON CAME OUT WITH THE SHEATH.
Patient problems: Obstruction/Occlusion
MAUDE report 8850357 ↗InjurySep 26, 2017Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN INTERVENTION ON A LEFT SUBCLAVIAN ARTERY 95% STENOSIS THE STENT DID NOT CROSS THE LESION.
Patient problems: Stenosis
MAUDE report 6894776 ↗MalfunctionSep 6, 2017Burst Container or Vessel
THE PHYSICIAN USED A STENT FOR A RIGHT COMMON ILIAC ARTERY TARGET IN A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR. THE VASCULATURE WAS HEAVILY CALCIFIED. THE STENT DEPLOYED CORRECTLY BUT THE BALLOON BURST AT 10 ATM.
Patient problems: No Information
MAUDE report 6844413 ↗InjuryMay 1, 2017Hole In Material
IT WAS REPORTED THAT THE STENT BALLOON HAD A HOLE IN IT AND THE PHYSICIAN HAD TO USE ANOTHER BALLOON TO TOUCH IT UP.
Patient problems: No Information
MAUDE report 6534709 ↗InjuryMay 11, 2016Leak/Splash
AS PART OF THE (B)(6) CLINICAL STUDY BEING CONDUCTED BY (B)(6) THE FOLLOWING EVENT WAS REPORTED: ON TWELVE MONTH FOLLOW UP CT SCAN, A DISTAL TYPE I ENDOLEAK WAS NOTED INVOLVING THE STENT. THERE WAS LOSS OF THE DISTAL SEAL IN THE RIGHT INTERNAL ILIAC ARTERY. AN ADDITIONAL STENT WAS PLACED INSIDE THE ORIGINAL STENT IN THE RIGHT INTERNAL ILIAC ARTERY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 5647934 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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