iCAST 85416Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00650862854169), received between Aug 5, 2016 and Dec 26, 2024 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A

  Patient problems: Foreign Body In Patient

  MAUDE report 21023688 ↗
• MalfunctionOct 6, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887420 ↗
• InjuryMar 24, 2023Off-Label Use; Premature Separation; Off-Label Use; Premature Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612990 ↗
• MalfunctionAug 15, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A Z-FEN CASE THE DOCTOR TRIED TO TRACK THE ICAST STENT INTO THE CELIAC ARTERY WHEN THE STENT DETACHED PREMATURELY FROM THE BALLOON. THE DOCTOR THEN REMOVED THE CATHETER AND THE SHEATH WITH THE STENT IN THE SHEATH. THE DOCTOR THEN TRIED THE SAME PROCEDURE AGAIN WITH A NEW ICAST STENT AND THE SAME SITUATION OCCURRED AGAIN. THE DOCTOR THEN USED A 7X38X120 ICAST STENT THAT WAS SUCCESSFUL. THE PATIENT DID NOT HAVE ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228052 ↗
• MalfunctionAug 15, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A Z-FEN CASE THE DOCTOR TRIED TO TRACK THE ICAST STENT INTO THE CELIAC ARTERY WHEN THE STENT DETACHED PREMATURELY FROM THE BALLOON. THE DOCTOR THEN REMOVED THE CATHETER AND THE SHEATH WITH THE STENT IN THE SHEATH. THE DOCTOR THEN TRIED THE SAME PROCEDURE AGAIN WITH A NEW ICAST STENT AND THE SAME SITUATION OCCURRED AGAIN. THE DOCTOR THEN USED A 7X38X120 ICAST STENT THAT WAS SUCCESSFUL. THE PATIENT DID NOT HAVE ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15226045 ↗
• InjuryApr 20, 2022Migration; Migration

  THE ICAST STENT WAS POSITIONED INTO THE CELIAC ARTERY AND THEN THE DOCTOR DECIDED IT WAS OVERSIZED AND REMOVED THE STENT TO BE PLACED INTO ANOTHER ARTERY. WHEN THE STENT WAS BEING REMOVED THE STENT BECAME DISLODGED FROM THE BALLOON. AT THIS POINT THE DOCTOR USED A SNARE WIRE TO GRAB INTO THE STENT AND KEEP IT MOUNTED ON THE PART OF THE BALLOON AND THEN REMOVE THE ENTIRE SYSTEM.

  Patient problems: Foreign Body Embolism

  MAUDE report 14164640 ↗
• InjuryJun 15, 2021Material Rupture; Separation Failure; Material Rupture; Separation Failure

  BALLOON RUPTURED AND BROKE OFF THE CATHETER WHILE ATTEMPTING TO REMOVE THE DEVICE. THE WIRE WAS ADVANCED TO THE CONTRALATERAL SIDE AND EXITED THROUGH PRE-EXISTING SHEATH. A DILATOR WAS USED TO PUSH THE RUPTURED BALLOON OVER THE WIRE INTO THE SHEATH ON THE OTHER SIDE. THE BALLOON WAS UNSUCCESSFULLY PUSHED INTO THE SHEATH. THE SHEATH WAS REMOVED WITH THE BALLOON HANGING OUT. STENT WAS SUCCESSFULLY IMPLANTED AND PATIENT WAS UNHARMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998321 ↗
• MalfunctionAug 11, 2020Deflation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated

  N/A.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10394339 ↗
• InjuryDec 20, 2019Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE STENT WAS ADVANCED PAST THE TIP OF THE WIRE. AS THE WIRE WAS ADVANCED IT WENT THROUGH THE CATHETER WALL. BOTH THE WIRE AND STENT WERE REMOVED FROM THE PATIENT WITHOUT ANY FURTHER ISSUE.

  Patient problems: No Information

  MAUDE report 9504216 ↗
• MalfunctionSep 27, 2018Material Puncture/Hole; Retraction Problem

  IT WAS REPORTED: THIS WAS BEING USED FOR A BILATERAL ILIAC CASE. THE CATHETER WAS ADVANCED TO THE LESION AND THE INFLATION DEVICE WAS BEING TURNED AND ONLY CONTRAST WAS SHOWING UNDER FLUORO. THE ACCOUNT ASSUMED THAT THERE WAS A HOLE IN THE BALLOON. THE STENT WAS ABLE TO BE RETRACTED BACK INTO THE SHEATH WITH NO HARM. THE HOSPITAL REPLACED WITH THE EXACT SIZE THEY HAD ON THE SHELF WITH NO ISSUES. THEY HAVE GIVEN ME THE PRODUCT TO SEND IN FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915807 ↗
• InjuryAug 21, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR THE SURGEON PLACED THE ICAST STENT INTO THE SHEATH AND THEN PULLED I OUT. WHEN THEY PULLED IT OUT OF THE SHEATH, THE STENT FELL OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802648 ↗
• MalfunctionAug 5, 2016Obstruction of Flow; No Flow; Obstruction of Flow

  DURING PREPARATION OF THIS ICAST STENT, THE SCRUB TECH ATTEMPTED TO FLUSH THE WIRE LUMEN PORT BUT WAS UNABLE TO PUSH SALINE THROUGH. THE PHYSICIAN SET THE DEVICE ASIDE AND USED ANOTHER STENT WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5851435 ↗

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