iCast Covered Stent System, 5mmX22mmX120cm 42522Recalls & reported problems
Atrium Medical Corporation · iCast Covered Stent System, 5mmX22mmX120cm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00650862425222), received between Apr 25, 2025 and Apr 11, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (P120003); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Failure to Advance1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Failure to Advance
IT WAS REPORTED THAT DURING A PMEG PROCEDURE THE ICAST STENT CAME OFF THE BALLOON ON BOTH SHAFTS WHILE TRYING TO ADVANCE THROUGH A SMALL FENESTRATION WITHOUT ADVANCING A SHEATH THROUGH THE FENESTRATION. NO HARM OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847824 ↗MalfunctionMay 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING THE FENESTRATED ENDOVASCULAR AORTIC PROCEDURE, ICAST BALLOON RUPTURED BEFORE REACHING 12ATM PRESSURE. HOWEVER, THE PROCEDURE WAS COMPLETED AND THE STENT WAS ABLE TO BE PLACED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22067130 ↗InjuryApr 25, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
Recalls under the same FDA submission
These recalls involve devices cleared under P120003. One submission often covers many models, so check the product and lot details in each record.
- Z-0291-2024 · Sep 21, 2023 · Open, ClassifiedAtrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6m
Other Iliac Covered Stent, Arterial devices
- GORE VIABAHN VBX Balloon Expandable Endo BXB073902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths19 reports
- iCast Covered Stent System, 6mmX16mmX120cm 42616Atrium Medical Corporation · Iliac Covered Stent, Arterial1 recall15 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB057902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB067902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB075902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB095902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB077902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB085902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths8 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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