iCast Covered Stent System, 7mmX22mmX80cm 48722Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00650862487220), received between Aug 21, 2025 and Sep 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

1 other recall cover devices cleared under the same FDA submission (P120003); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Dislodged or Dislocated

  During placement of the iCast stent in the SMA, after successful cannulation and guidewire exchange to a Rosen wire, the physician advanced the iCast through a 7 Fr sheath. While attempting deployment, the stent and balloon detached from each other. The detached iCast was successfully retrieved using a Goose Neck snare. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913723 ↗
• MalfunctionJun 8, 2026Accessory Incompatible

  DURING A FEVAR PROCEDURE WITH A TERUMO TREO FENESTRATED DEVICE, FOUR VISCERAL VESSELS (BILATERAL RENAL ARTERIES, SMA, AND CELIAC) WERE STENTED USING ICAST STENTS. WHILE ATTEMPTING TO ADVANCE AN ICAST STENT INTO THE CELIAC ARTERY VIA A 6.5 FR BAYLISS STEERABLE SHEATH, THE STENT FAILED TO CROSS THE FENESTRATION. THE DEVICE WAS WITHDRAWN TO ALLOW PRE-DILATION; HOWEVER, DURING REMOVAL, THE STENT CAUGHT ON THE SHEATH¿S HEMOSTATIC VALVE AND DISLODGED. THE STENT WAS RETRIEVED INTACT. A SECOND ICAST STENT WAS SUCCESSFULLY DEPLOYED. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429594 ↗
• MalfunctionAug 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE AND ICAST STENT FELL OFF THE BALLOON AND WAS NOT DEPLOYED IN THE PATIENT. NO HARM, ADDITIONAL PROCEDURES OR EXTENDED SURGERY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863750 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120003. One submission often covers many models, so check the product and lot details in each record.

• Z-0291-2024 · Sep 21, 2023 · Open, Classified
  Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6m