iCAST 85445Recalls & reported problems
Atrium Medical Corporation · iCAST COVERED STENT, 7MMX22MMX80CM · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00650862854459), received between Mar 17, 2017 and Sep 24, 2024 — classified as 4 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
- Break1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Device-Device Incompatibility1
- Difficult or Delayed Positioning1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information2
- No Consequences Or Impact To Patient2
- Aneurysm1
- Calcium Deposits/Calcification1
- No Information1
- Obstruction/Occlusion1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 22, 2023Premature Activation; Premature Activation
N/A.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17804600 ↗MalfunctionJul 20, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
STENT SLIPPED OFF BALLOON DURING INSERTION AND HAD TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064477 ↗InjuryJul 13, 2022Separation Problem; Separation Problem
BALLOON SEPARATED FROM CATHETER AND WAS SUCCESSFULLY RETRIEVED BY SURGEON. STENTING SMA DURING A ZFEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15003380 ↗InjuryOct 3, 2021Device-Device Incompatibility; Obstruction of Flow; Device-Device Incompatibility
InjurySep 24, 2021Migration or Expulsion of Device
MalfunctionAug 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
ICAST WAS INSERTED THROUGH SHEATH IN FEMORAL ARTERY TO DEPLOY IN RENAL ARTERY. WHEN THE PHYSICIAN WENT TO INFLATE THE BALLOON, THE BALLOON BARELY INFLATED. WE NOTICED THAT THERE WAS A LEAK WHERE THE ICAST¿S CATHETER CONNECTS TO ITS PLASTIC HUB WHERE YOU CONNECT THE INSUFFLATOR. THE ICAST BOX WAS IN MINT CONDITION SO IT WASN¿T A SHIPPING OR HANDLING ISSUE THAT MAY HAVE CAUSED THIS. THE FIELD SALES REP, WAS IN THE CASE AND SAW THERE WAS NO ERROR ON THE USER END. THE PHYSICIAN HAD TO HAVE A STAFF MEMBER PINCH WHERE IT WAS LEAKING SO HE COULD INFLATE THE BEST HE COULD TO SEMI-DEPLOY THE STENT IN ORDER TO RETRIEVE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12352033 ↗MalfunctionApr 21, 2021Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Detachment of Device or Device Component
N/A.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11704735 ↗MalfunctionMay 13, 2020Device Dislodged or Dislocated
MalfunctionNov 19, 2019Break
InjuryMar 17, 2017Detachment Of Device Component
IT WAS REPORTED THAT THE PHYSICIAN WAS DELIVERING A STENT TO THE SUPERIOR MESENTERIC ARTERY AND THE STENT CAME OFF THE BALLOON WITHIN THE SHEATH. THE PHYSICIAN THEN RETRACTED THE SHEATH, STENT AND BALLOON. ANOTHER STENT WAS THEN SUCCESSFULLY DELIVERED. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6414410 ↗
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
- iCAST 85453Atrium Medical Corporation · Prosthesis, tracheal, expandable43 reports
- WALLSTENT™ BILIARY H965430500Boston Scientific Corporation · Prosthesis, tracheal, expandable13 reports
- iCAST 85419Atrium Medical Corporation · Prosthesis, tracheal, expandable13 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.