iCAST 85412Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00650862854121), received between Sep 13, 2016 and Aug 16, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2022Failure to Advance; Failure to Advance

  DURING A FENESTRATED AAA PROCEDURE, AN ICAST STENT WAS ADVANCED THROUGH A MEDTRONIC 7F APTUS STEERABLE SHEATH THROUGH A FENESTRATION IN THE COOK ZENITH FENESTRATED AAA GRAFT TO ACCESS A HIGHLY STENOTIC CELIAC ARTERY. DESPITE ATTEMPTS TO PREDILATE THE CELIAC STENOSIS WITH A BALLOON, THE ICAST 6X38X120 WAS UNABLE TO BE DELIVERED ACROSS THE LESION AND WAS WITHDRAWN FROM THE PATIENT. AS THE STENT WAS BEING REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE STENT HAD LOOSENED FROM THE DELIVERY BALLOON AS THE STENT EXITED THE RUBBER VALVE OF THE APTUS SHEATH. THAT STENT WAS PLACED ASIDE NOT TO BE USED AGAIN AND THE PHYSICIAN REQUESTED ANOTHER 6X38X120 STENT TO MAKE ANOTHER ATTEMPT WHICH WAS UNSUCCESSFUL IN CROSSING THE LESION. THE SECOND STENT ALSO BECAME DISLODGED UPON REMOVAL FROM THE APTUS SHEATH AT THE VALVE. A THIRD STENT, A 6X22X120 WAS THEN SELECTED WITH THE SAME RESULT: DID NOT CROSS LESION, AND STENT BECAME DISLODGED UPON REMOVAL FROM THE APTUS SHEATH AT THE VALVE. A FOURTH ICAST, 6X22X120, WAS SUCCESSFULLY DEPLOYED AT THE FENESTRATION OF THE COOK ENDOGRAFT TO ACHIEVE A HEMOSTATIC SEAL WITH THE ENDOGRAFT. FURTHER STEPS WERE TAKEN TO DILATE THE LESION DISTAL TO THE FENESTRATION WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232324 ↗
• MalfunctionAug 15, 2022Failure to Advance; Failure to Advance

  DURING A FENESTRATED AAA PROCEDURE, AN ICAST STENT WAS ADVANCED THROUGH A MEDTRONIC 7F APTUS STEERABLE SHEATH THROUGH A FENESTRATION IN THE COOK ZENITH FENESTRATED AAA GRAFT TO ACCESS A HIGHLY STENOTIC CELIAC ARTERY. DESPITE ATTEMPTS TO PREDILATE THE CELIAC STENOSIS WITH A BALLOON, THE ICAST 6X38X120 WAS UNABLE TO BE DELIVERED ACROSS THE LESION AND WAS WITHDRAWN FROM THE PATIENT. AS THE STENT WAS BEING REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE STENT HAD LOOSENED FROM THE DELIVERY BALLOON AS THE STENT EXITED THE RUBBER VALVE OF THE APTUS SHEATH. THAT STENT WAS PLACED ASIDE NOT TO BE USED AGAIN AND THE PHYSICIAN REQUESTED ANOTHER 6X38X120 STENT TO MAKE ANOTHER ATTEMPT WHICH WAS UNSUCCESSFUL IN CROSSING THE LESION. THE SECOND STENT ALSO BECAME DISLODGED UPON REMOVAL FROM THE APTUS SHEATH AT THE VALVE. A THIRD STENT, A 6X22X120 WAS THEN SELECTED WITH THE SAME RESULT: DID NOT CROSS LESION, AND STENT BECAME DISLODGED UPON REMOVAL FROM THE APTUS SHEATH AT THE VALVE. A FOURTH ICAST, 6X22X120, WAS SUCCESSFULLY DEPLOYED AT THE FENESTRATION OF THE COOK ENDOGRAFT TO ACHIEVE A HEMOSTATIC SEAL WITH THE ENDOGRAFT. FURTHER STEPS WERE TAKEN TO DILATE THE LESION DISTAL TO THE FENESTRATION WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228128 ↗
• MalfunctionSep 27, 2018Detachment of Device or Device Component

  DR. (B)(6) PUT THE STENT THROUGH A 7FR STEERABLE SHEATH VIA THE FEMORAL ARTERY AND ATTEMPTED TO STENT THE SMA. WIRE WAS PAST THE LESION AND THE STENT WAS PROTECTED TO LESION. VERY CALCIFIED LESION AT THE OSTIUM. TRIED SEVERAL TIMES TO CROSS, DECIDED TO TAKE THE STENT OUT AND USE A 6FR. GUIDE TO CROSS 1ST. WHEN (B)(6) REMOVED THE ICAST FROM THE BODY, THE STENT DETACHED FROM THE BALLOON. ANOTHER STENT WAS INTRODUCED AND SUCCESSFULLY IMPLANTED WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915508 ↗
• InjuryJan 16, 2017Difficult to Insert; Loose or Intermittent Connection

  THE PHYSICIAN WAS TREATING A MESENTERIC STENOSIS WITH A STENT. HE ATTEMPTED TO PLACE A 7FR COMPATIBLE STENT INTO A 6FR CORDIS SHEATH. WHEN THE STENT DID NOT GO INTO THE SHEATH THEY UPSIZED TO A 7FR WITH A TOUEY ATTACHMENT ON IT AND THE STENT AGAIN DID NOT ENTER THE SHEATH. THEY REMOVED THE ATTACHMENT AND ATTEMPTED TO INTRODUCE THE STENT AGAIN WHEN IT WAS NOTICED THAT THE STENT WAS LOOSE ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6253070 ↗
• InjurySep 13, 2016Failure to Advance

  THE PHYSICIAN WAS ATTEMPTING TO PLACE A STENT INTO A CAROTID ARTERY TO COVER A LESION. THE STENT WOULD NOT CROSS THE LESION. THE PHYSICIAN STATED THAT THIS WAS NOT ATTRIBUTED TO THE DEVICE. THE PHYSICIAN REMOVED THE ICAST WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5946627 ↗

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, Classified
  iCast 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 · Terminated
  Atrium 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