iCAST 85453Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 6MMX22MMX120CM · Class 2 · Implant
Quick summary
This Atrium Medical iCAST covered stent is an expandable scaffold that holds open a narrowed artery. Its 43 reports mostly describe trouble advancing or positioning it, leaking, and blocked blood flow; 26 reports involved injuries and no deaths. Some describe the stent coming loose from its delivery balloon and drifting into an artery, where it was snared out. No recalls name this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00650862854534), received between Apr 14, 2016 and Nov 28, 2023 — classified as 26 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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
- Adverse Event Without Identified Device or Use Problem5
- Leak/Splash5
- Device-Device Incompatibility3
- Failure to Advance3
- Obstruction of Flow3
- Positioning Problem3
- Activation, Positioning or Separation Problem2
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Information8
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient5
- Blood Loss4
- No Consequences Or Impact To Patient4
- Obstruction/Occlusion4
- Occlusion3
- Aneurysm2
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 19, 2022Premature Separation; Premature Separation
DURING INSERTION OF ICAST DELIVERY CATHETER INTO SHEATH INTO PATIENT, STENT DISLODGED FROM THE DELIVERY BALLOON. LOOSE STENT MIGRATED TO THE PATIENT'S ILIAC ARTERY WHERE AN INTERVENTION OCCURRED WHICH THE STENT WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. NO ADDITIONAL HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16011040 ↗MalfunctionNov 28, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MEDWATCH REPORT 2000330000-20228074 RECEIVED. DURING PROCEDURE MD WAS TRYING TO LINE UP STENT ENDOVASCULARLY, DECIDED TO CHANGE COURSE AND REMOVE CATHETER THAT HOUSED STENT. WHEN REMOVING CATHETER THAT STENT RELEASED ITSELF FROM ITS HOUSING UNIT WITHOUT BEING "DEPLOYED". ORIGINAL INTENDED PROCEDURE: ENDOGRAFT REPAIR OF COMPLEX PARARENAL ANEURYSM USING PHYSICIAN MODIFIED COOK FENESTRATED GRAFT. RIGHT BRACHIAL CUTDOWN FOR RIGHT RENAL ARTERY STENTING. OPEN REPAIR OF RIGHT COMMON FEMORAL ARTERY WITH ENDARTERECTOMY AND BOVINE PERICARDIAL PATCH GRAFT ANGIOPLASTY. PROBLEM: DEVICE FAILED, DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15872205 ↗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 15232571 ↗MalfunctionJul 20, 2022Positioning Failure; Positioning Failure
SURGEON INSERTED ICAST STENT ON A 120 CM DELIVERY SYSTEM INTO A 110 CM SHEATH YET IT DIDN¿T COME OUT ON THE OTHER SIDE. HE REMOVED THE STENT, OPENED ANOTHER 120 CM ICAST & LAID THEM NEXT TO EACH OTHER ON A TABLE, AND ONE WAS 5-10 CM SHORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064478 ↗InjuryOct 3, 2021Collapse; Collapse
InjuryOct 3, 2021Device-Device Incompatibility; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
MalfunctionSep 13, 2021Positioning Problem; No Apparent Adverse Event; No Apparent Adverse Event
InjurySep 1, 2021Structural Problem; Device-Device Incompatibility; Device-Device Incompatibility
NEW EVENT OCCURRED ON (B)(6) 2020, PATIENT WAS DIAGNOSED WITH A LEFT RENAL ARTERY WITHIN THE STENT OCCLUSION. THERE WAS NO TREATMENT FOR THIS EVENT. RELATED MDR: 3011175548-2021-00870. PREVIOUS EVENT: PATIENT HAD AN ICAST STENT IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, POST-PROCEDURE IMAGING WAS PERFORMED. THE SITE NOTED AND THE (B)(6) LAB EVALUATION REVEALED THAT THE LEFT RENAL ARTERY WITHIN THE STENT WAS NOT PATENT. THERE WAS NO ENDOLEAK, SEPARATION OF COMPONENTS, OR DEVICE INTEGRITY ISSUES. A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2016, THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO TREAT THE OCCLUSION OF THE LEFT RENAL ARTERY STENT. TREATMENT INCLUDED PERCUTANEOUS PLACEMENT OF A COOK 7 MM X 20 MM FORMULA 418 STENT. THE SITE INDICATED THE SECONDARY INTERVENTION WAS SUCCESSFUL.
Patient problems: Obstruction/Occlusion
MAUDE report 12408175 ↗InjuryAug 22, 2021Leak/Splash; Device-Device Incompatibility; Device-Device Incompatibility
PATIENT HAD AN ICAST STENT IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, POST-PROCEDURE IMAGING WAS PERFORMED. THE SITE NOTED AND THE CORE LAB EVALUATION REVEALED THAT THE LEFT RENAL ARTERY WITHIN THE STENT WAS NOT PATENT. THERE WAS NO ENDOLEAK, SEPARATION OF COMPONENTS, OR DEVICE INTEGRITY ISSUES. A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2016, THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO TREAT THE OCCLUSION OF THE LEFT RENAL ARTERY STENT. TREATMENT INCLUDED PERCUTANEOUS PLACEMENT OF A COOK 7 MM X 20 MM FORMULA 418 STENT. THE SITE INDICATED THE SECONDARY INTERVENTION WAS SUCCESSFUL.
Patient problems: Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Obstruction/Occlusion
MAUDE report 12352020 ↗MalfunctionJun 29, 2021Component or Accessory Incompatibility; Component or Accessory Incompatibility
InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem
InjuryJul 29, 2020Obstruction of Flow
MalfunctionMar 17, 2020Leak/Splash
IT WAS REPORTED THAT A PATIENT HAD 2 STENTS PLACED IN THE RIGHT RENAL ARTERY. A TYPE III ENDOLEAK WAS NOTED RIGHT AFTER THE STENTS WERE PLACED. THE INTERVENTION WAS SUCCESSFUL AND THE LEAK WAS RESOLVED. BLOOD LOSS WAS 200 ML.
Patient problems: Blood Loss
MAUDE report 9845854 ↗MalfunctionMar 17, 2020Leak/Splash
InjuryMar 5, 2020Complete Blockage
86 DAYS POST-PROCEDURE THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION OF THE RIGHT RENAL STENT, OCCLUSION OR THE LEFT RENAL STENT, BILATERAL RENAL INFARCT, AND LEFT ILIAC GRAFT OCCLUSION. RENAL OCCLUSIONS WERE TREATED BY THROMBECTOMY AND ADDITIONAL STENT PLACEMENT. OCCLUSION IN THE ILIAC GRAFT WAS TREATED BY FEMORAL-FEMORAL BYPASS.
Patient problems: Embolism; Occlusion; Renal Failure
MAUDE report 9796159 ↗InjuryMar 5, 2020Obstruction of Flow
86 DAYS POST-PROCEDURE THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION OF THE RIGHT RENAL STENT, OCCLUSION OR THE LEFT RENAL STENT, BILATERAL RENAL INFARCT, AND LEFT ILIAC GRAFT OCCLUSION. RENAL OCCLUSIONS WERE TREATED BY THROMBECTOMY AND ADDITIONAL STENT PLACEMENT. OCCLUSION IN THE ILIAC GRAFT WAS TREATED BY FEMORAL-FEMORAL BYPASS.
Patient problems: Ischemia; Occlusion; Renal Failure
MAUDE report 9796123 ↗InjuryJan 15, 2020Obstruction of Flow
IT WAS REPORTED THAT THE DAY FOLLOWING OBSERVATION OF THE RIGHT RENAL STENT OCCLUSION, THE PATIENT WAS TREATED BY PERFORMING A THROMBECTOMY AND PLACEMENT OF A VBX STENT INTO THE RIGHT RENAL ARTERY OVER THE PREVIOUSLY PLACED ICAST STENT.
Patient problems: Thrombosis
MAUDE report 9591060 ↗MalfunctionJan 13, 2020Failure to Advance
THE PHYSICIAN STATED THAT THE STENT CATHETER WOULD NOT CROSS THE INTENDED LESION.
Patient problems: No Information
MAUDE report 9584505 ↗InjuryNov 21, 2019Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED STENT WAS USED DURING A PROCEDURE WITH A PATIENT. THE STENT WAS NOT DEPLOYED, BUT IT WAS INSERTED INTO THE SHEATH/PATIENT. UPON DISCOVERY BY THE CIRCULATING RN, THE STENT WAS REMOVED FROM THE PATIENT AND A NEW STENT WAS PLACED.
Patient problems: No Information
MAUDE report 9357024 ↗MalfunctionAug 20, 2019Positioning Problem
CUSTOMER STATED THAT THE STENT WAS POSITIONED IN THE RENTAL ARTERY. DURING POSITIONING THE STENT CAME PARTIALLY OFF THE BALLOON. THEY WERE ABLE TO DEPLOY STENT. THE STENT WAS POST DILATED WITH DIFFERENT BALLOON AND FOLLOW UP ANGIO TAKEN. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8910341 ↗InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem
MalfunctionAug 9, 2019Loose or Intermittent Connection
InjuryJul 19, 2019Positioning Problem; Physical Resistance/Sticking
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
- 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
- iCAST 85424Atrium Medical Corporation · Prosthesis, tracheal, expandable9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.