iCASTRecalls & reported problems across all models
Atrium Medical Corporation · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 197
- Deaths reported
- 0
- Injuries reported
- 112
- Recalls
- 0
We found 29 models of iCAST by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 197 adverse event reports in the FDA's MAUDE database, received between Apr 14, 2016 and Jan 3, 2025 — classified as 112 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (20 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported iCAST problems
Device problems
- Activation, Positioning or Separation Problem20
- Detachment Of Device Component16
- Detachment of Device or Device Component14
- Device Dislodged or Dislocated11
- Failure to Advance11
- Adverse Event Without Identified Device or Use Problem9
- Material Rupture9
- Burst Container or Vessel8
Patient problems
- No Consequences Or Impact To Patient47
- No Clinical Signs, Symptoms or Conditions40
- No Information36
- No Known Impact Or Consequence To Patient26
- Occlusion8
- Blood Loss7
- No Code Available7
- Obstruction/Occlusion7
iCAST models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iCAST 85453Prosthesis, tracheal, expandable43 reports
- iCAST 85419Prosthesis, tracheal, expandable13 reports
- iCAST 85416Prosthesis, tracheal, expandable12 reports
- iCAST 85445Prosthesis, tracheal, expandable12 reports
- iCAST 85455Prosthesis, tracheal, expandable11 reports
- iCAST 85414Prosthesis, tracheal, expandable10 reports
- iCAST 85424Prosthesis, tracheal, expandable9 reports
- iCAST 85415Prosthesis, tracheal, expandable8 reports
- iCAST 85420Prosthesis, tracheal, expandable8 reports
- iCAST 85451Prosthesis, tracheal, expandable8 reports
- iCAST 85443Prosthesis, tracheal, expandable7 reports
- iCAST 85444Prosthesis, tracheal, expandable7 reports
- iCAST 85417Prosthesis, tracheal, expandable6 reports
- iCAST 85418Prosthesis, tracheal, expandable6 reports
- iCAST 85450Prosthesis, tracheal, expandable6 reports
- iCAST 85412Prosthesis, tracheal, expandable5 reports
- iCAST 85441Prosthesis, tracheal, expandable4 reports
- iCAST 85406Prosthesis, tracheal, expandable3 reports
- iCAST 85407Prosthesis, tracheal, expandable3 reports
- iCAST 85409Prosthesis, tracheal, expandable3 reports
- iCAST 85452Prosthesis, tracheal, expandable3 reports
- iCAST 85404Prosthesis, tracheal, expandable2 reports
- iCAST 85440Prosthesis, tracheal, expandable2 reports
- iCAST 85403Prosthesis, tracheal, expandable1 report
- iCAST 85405Prosthesis, tracheal, expandable1 report
- iCAST 85408Prosthesis, tracheal, expandable1 report
- iCAST 85410Prosthesis, tracheal, expandable1 report
- iCAST 85413Prosthesis, tracheal, expandable1 report
- iCAST 85442Prosthesis, tracheal, expandable1 report
Recent iCAST adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Material Integrity Problem; Material Integrity Problem
NA.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21074722 ↗InjuryDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionSep 24, 2024Difficult to Advance; Difficult to Advance
MalfunctionSep 16, 2024
THE STENT GOT CAUGHT ON SOMETHING AND COULDN'T ADVANCE. STENT REMOVED FROM PATIENT AND NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20223667 ↗MalfunctionJun 7, 2024Fracture; Activation Failure; Fracture; Activation Failure
DURING THE PROCEDURE THE STENT BROKE WHILE BEING DEPLOYED, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19489965 ↗MalfunctionJan 29, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MalfunctionNov 28, 2023Failure to Advance; Failure to Advance
DURING A FEVAR PROCEDURE THE PHYSICIAN ATTEMPTED TO STENT A RENAL ARTERY THROUGH AN AORTIC ENDOGRAFT. DURING STENT ADVANCEMENT OVER AN .035 ROSEN WIRE THROUGH A 6F COOK ANSEL 1 SHEATH, PHYSICIAN REPORTED EXPERIENCING AN USUAL AMOUNT OF RESISTANCE AS SHE ATTEMPTED TO ADVANCE THE STENT. STENT WAS REMOVED AND A NEW 6X22X120 STENT WAS SELECTED. THAT NEW STENT ADVANCED THROUGH THE SAME ANSEL 1 SHEATH WITHOUT ANY RESISTANCE AND WAS SUCCESSFULLY DEPLOYED AS INTENDED. THE SECOND RENAL ARTERY WAS THEN STENTED WITH YET ANOTHER 6X22X120 SUCCESSFULLY WITHOUT ISSUE. THE STENT THAT ENCOUNTERED RESISTANCE WAS EXAMINED UPON REMOVAL FROM PATIENT AND DID NOT APPEAR TO BE DAMAGED, STENT APPEARED TO BE IN CORRECT POSITION BETWEEN THE BALLOON MARKER BANDS, AND STENT DID NOT APPEAR TO BE DAMAGED. NO NEGATIVE IMPACTS TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18220519 ↗InjuryOct 16, 2023Premature Separation; Premature Separation
WHILE THE VASCULAR SURGEON WAS DEPLOYING AN ICAST STENT IN ILIAC ARTERY, DEPLOYED THROUGH 7F SHEATH. EVERYTHING WENT AS NORMAL, STENT DEPLOYED IN ILIAC ARTERY AND NOTICED BALLOON DETACHED FROM DELIVERY SYSTEM DURING REMOVAL OF DELIVERY CATHETER. BALLOON WAS SNARED AND REMOVED THROUGH SHEATH. NO ADVERSE ISSUES TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17941134 ↗MalfunctionOct 9, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
STENT HAS SNAPPED OFF WITHIN THE SHEATH, ENTIRE SHEATH WAS REMOVED AND UPON INSPECTION SAW THAT BALLOON SNAPPED OFF THE SHAFT PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17895511 ↗MalfunctionOct 9, 2023Material Rupture; Activation Failure; Material Rupture; Activation Failure
DURING THE PROCEDURE FOR FENESTRATED ENDOGRAPH, AN ICAST STENT WAS SELECTED AND DEEMED DEFECTIVE AS THE BALLOON POPPED UPON INFLATION TO EXPAND THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17895505 ↗MalfunctionOct 6, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MalfunctionSep 22, 2023Premature Activation; Premature Activation
N/A.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17804600 ↗InjuryMar 24, 2023Off-Label Use; Premature Separation; Off-Label Use; Premature Separation
MalfunctionMar 8, 2023Activation Failure; Activation Failure
MalfunctionFeb 9, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
Other Atrium Medical Corporation products
- ADVANTA SLIDER GDS51 models · 76 reports · 51 recalls
- FLIXENE SLIDER GDS17 models · 52 reports · 17 recalls
- PROLITE23 models · 515 reports
- OASIS6 models · 270 reports · 4 recalls
- PROLOOP12 models · 355 reports
- EXPRESS3 models · 142 reports · 4 recalls
- OCEAN10 models · 111 reports · 4 recalls
- C-QUR V-PATCH3 models · 165 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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