iCAST 85419Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00650862854190), received between Oct 6, 2016 and Oct 4, 2019 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2019Improper or Incorrect Procedure or Method

  N/A

  Patient problems: No Code Available

  MAUDE report 9158578 ↗
• MalfunctionAug 20, 2019Material Rupture

  THE STENT WAS OPENED AND DEPLOYED OUT OF THE BODY (IN ORDER TO ONLY USE THE BALLOON) AND THE BALLOON RUPTURED.

  Patient problems: No Information

  MAUDE report 8910715 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem

  THE A STENT WAS DEPLOYED AND RESULTED IN UNEXPECTED BLEEDING. THE SECOND STENT WAS PLACED TO STOP THE BLEEDING THAT HAD RESULTED FROM STENT NUMBER 1. THERE IS NO ALLEGATION OF STENT MALFUNCTION FOR THIS SECOND STENT. MDR CREATED IN ORDER TO RESPOND TO THE USER FACILITY MEDWATCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8910539 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Blood Loss

  MAUDE report 8910340 ↗
• MalfunctionApr 23, 2019Complete Blockage; Detachment of Device or Device Component

  USER FACILITY MDR RECEIVED: (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS LEFT FEMORAL ARTERY ISOLATION AND RECANNULIZATION OF OCCLUDED EXTERNAL AND COMMON ILIAC ARTERY. WHILE DEPLOYING THE STENT, THE BALLOON ON THE STENT BECAME DETACHED AND HAD TO BE SNARED FROM THE ILIAC ARTERY. ALL PARTS WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8539406 ↗
• InjurySep 26, 2017Detachment Of Device Component; Entrapment of Device

  IT WAS REPORTED THAT THE STENT WAS DELIVERED TO THE LEFT ILIAC ARTERY BUT WAS DEEMED TO BE TOO LONG. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT IT CAME OFF THE BALLOON AND REMAINED IN THE LEFT ILIAC ARTERY RESULTING IN THE PHYSICIAN PLACING ANOTHER DEVICE TO SECURE IT IN THE ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6894792 ↗
• MalfunctionApr 6, 2017Difficult to Advance

  THE PHYSICIAN WENT TO PUT THE STENT ON A 0.035 AMPLATZ WIRE. HE STATED THERE WAS AN ISSUE WITH THE LUMEN OF THE CATHETER AND HE WAS UNABLE TO ADVANCE THE CATHETER FULLY INTO THE SHEATH. THE CATHETER WAS REMOVED BEFORE IT COULD BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6464692 ↗
• InjuryApr 6, 2017Difficult to Remove; Material Separation; Mechanical Jam

  THE STENT WAS DEPLOYED. THE PHYSICIAN WENT TO REMOVE THE CATHETER FROM A TERUMO DESTINATION 7FR 90 CM SHEATH AND THE CATHETER WAS STUCK AND WOULD NOT COME OUT OVER A ROSEN 0.035 X 260 CM WIRE. AFTER ROUGHLY FIVE MINUTES OF TRYING TO REMOVE THE CATHETER, THE HUB BECAME SEPARATED FROM THE CATHETER.

  Patient problems: No Information

  MAUDE report 6464684 ↗
• InjuryDec 28, 2016Break

  DURING A PROCEDURE, THE ICAST STENT WAS DEPLOYED SUCCESSFULLY. WHEN REMOVING THE CATHETER, THE BALLOON BECAME HUNG UP INSIDE THE SHEATH. WHEN THE DOCTORS TRIED TO FORCE THE REMOVAL, THE Y HUB AT THE DISTAL END OF THE CATHETER BROKE FORCING THE DOCTORS TO REMOVE THE DEVICE AND THE SHEATH AT THE SAME TIME.

  Patient problems: No Information

  MAUDE report 6208272 ↗
• InjuryDec 9, 2016Break; Physical Resistance

  DURING AN ENDOVASCULAR ANEURYSM REPAIR WITH SUBCLAVIAN APPROACH TO DELIVER THE STENTS. WHILE ATTEMPTING TO DELIVER THE STENT TO THE LEFT HYPOGASTRIC ARTERY THE SHAFT ACCORDIANED/CRUMBLED. THERE WERE NO ACUTE ANGLES BUT THERE WAS RESISTANCE. THE DEVICE WAS IN THE SHEATH WHEN THIS OCCURRED AND IT WAS REMOVED AND DISCARDED. NO HARM CAME TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6157573 ↗
• InjuryOct 19, 2016Difficult to Advance; Material Deformation

  THE PROCEDURE WAS A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR. THE ACCESS WAS FEMORAL CONTRALATERAL APPROACH. IT WAS VERY TIGHT GOING UP AND OVER. THE PHYSICIAN PUSHED VERY HARD SEVERAL TIMES. HE THEN PULLED BACK AND THE CATHETER ACCORDIONED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6041679 ↗
• InjuryOct 19, 2016Material Deformation

  RESISTANCE WAS FELT WHILE ATTEMPTING TO GO FROM THE GUIDE. THE PHYSICIAN PUSHED VERY HARD SEVERAL TIMES. HE THEN PULLED BACK AND THE CATHETER ACCORDIONED TOWARDS THE PROXIMAL END.

  Patient problems: No Code Available

  MAUDE report 6041671 ↗
• InjuryOct 6, 2016Bent

  IT WAS REPORTED THAT WHEN THE STENT WAS BEING PUSHED THROUGH THE SHEATH IT BECAME BENT. THE STENT WAS WITHDRAWN FROM THE PATIENT PRIOR TO DEPLOYMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6004353 ↗

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