iCAST 85417Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00650862854176), received between May 6, 2016 and Mar 15, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2020Failure to Advance

  CUSTOMER REPORT OF ICAST STENT CATHETER NOT ABLE TO CROSS LESION TO TREAT INTENDED STENOSIS.

  Patient problems: No Information

  MAUDE report 9833185 ↗
• InjuryMay 18, 2017Positioning Problem

  IT WAS REPORTED THAT THE STENT DID NOT CROSS. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6575747 ↗
• InjuryNov 18, 2016Burst Container or Vessel; Detachment Of Device Component; Difficult to Remove

  THE PHYSICIAN PLACED A STENT IN THE RIGHT COMMON ILIAC ARTERY. IT WAS NOTED THAT THE BALLOON HAD POPPED BECAUSE BLOOD WAS NOTICED IN THE INFLATOR. WHILE TRYING TO RETRIEVE THE POPPED BALLOON IT APPEARED TO BE SHEARED OFF THE STENT CATHETER. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BALLOON UNSUCCESSFULLY. THE DECISION WAS MADE TO LEAVE THE BALLOON IN THE COMMON ILIAC AND PLACE ADDITIONAL STENTS OVER IT TO MAINTAIN BLOOD FLOW. THE SOLUTION WAS SUCCESSFUL AND THE PATIENT WAS UNHARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6112053 ↗
• InjuryOct 6, 2016Bent; Failure to Advance

  THE PHYSICIAN WAS TREATING AN ENDOVASCULAR ANEURYSM REPAIR WITH AN OVATION STENT GRAFT. HE WAS USING A STENT TO PRESERVE THE PATIENT'S RIGHT HYPOGASTRIC ARTERY. AS HE WAS CROSSING THE STENT OVER THE TOP OF THE GRAFT HE BEGAN TO FEEL A LOT OF RESISTANCE. AS HE WAS ADVANCING THE DEVICE HE SAID THE SHAFT WAS BENDING. ULTIMATELY HE ENDED UP REMOVING THE STENT BECAUSE HE WAS NOT ABLE TO ADVANCE IT ANY FURTHER.

  Patient problems: No Information

  MAUDE report 6002417 ↗
• InjuryOct 6, 2016Activation, Positioning or Separation Problem

  DURING AN ENDOVASCULAR ANEURYSM REPAIR WITH AN OVATION STENT GRAFT, THE MD WAS ADVANCING THE DEVICE HE SAID THE SHAFT WAS BUCKLING. HE WAS ABLE TO DELIVER THIS ICAST BUT WITH A GREAT DEAL OF RESISTANCE.

  Patient problems: No Information

  MAUDE report 6002415 ↗
• InjuryMay 6, 2016Detachment Of Device Component

  THE PHYSICIAN ATTEMPTED TO PLACE THE STENT INTO AN ILIAC ARTERY. THE STENT CAME OFF THE BALLOON BUT WAS REMOVED SUCCESSFULLY. NO PATIENT HARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636471 ↗

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