iCast Covered Stent System, 6mmX22mmX120cm 42622Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00650862426229), received between Mar 21, 2025 and May 4, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Patient-Device Incompatibility

  DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CROSS A STENOTIC AREA USING A 6-45 ANSEL SHEATH; HOWEVER, THIS WAS UNSUCCESSFUL VIA THE INITIAL APPROACH. ALTERNATE ACCESS WAS OBTAINED VIA THE LEFT EXTERNAL APPROACH, AND THE STENOSIS IN THE PROXIMAL LEFT COMMON ILIAC ARTERY WAS SUCCESSFULLY CROSSED USING AN AMPLATZ WIRE. AN ICAST STENT WAS ADVANCED BUT BECAME DISLODGED FROM THE BALLOON PRIOR TO DEPLOYMENT. THE DISLODGED STENT WAS SUCCESSFULLY SNARED AND RETRIEVED. SHOCKWAVE THERAPY WAS THEN PERFORMED TO TREAT THE STENOSIS, AND NO STENT WAS IMPLANTED. THE SHEATH AND DISLODGED STENT WERE REMOVED FROM THE PATIENT. NO HARM WAS REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 25067582 ↗
• MalfunctionNov 7, 2025Off-Label Use; Device Fell; Off-Label Use; Device Fell

  A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING THE ICAST COVERED STENT SYSTEM, DURING WHICH THREE ICAST STENTS FELL OFF THE BALLOON CATHETER. THE PHYSICIAN PLACED AN AORTIC GRAFT AND LASER FENESTRATION TO INSERT THE STENTS INTO THE RENAL ARTERIES, BUT COULDN'T GET THE SHEATH IN THE VESSELS SO THE PHYSICIAN PLACED THE ICAST STENTS VIA BARE BACK. ONCE THE ICAST STENTS WERE OUT OF THE SHEATH THE STENTS BECAME CAUGHT ON EITHER A STENT IN THE AORTIC GRAFT OR THE BURNT HOLES. PRIOR TO THE ICAST STENTS, THE PHYSICIAN TRIED TO USE A COMPETITOR'S STENT WITH SIMILAR ISSUES. A 6MM X 22MM ICAST STENT WAS SUCCESSFULLY PLACED IN THE RIGHT RENAL ARTERY, WHILE A VBX STENT WAS USED IN THE LEFT RENAL ARTERY AFTER ATTEMPTS TO PLACE TWO 7MM X 22MM ICAST STENTS WERE UNSUCCESSFUL. THERE WAS NO ADVERSE EVENT OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497525 ↗
• InjuryApr 28, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE ICAST STENT FELL OFF THE BALLOON WHILE TRYING TO POSITION IT IN THE RIGHT RENAL AND SMA. THE STENTS WERE RECOVERED AND TAKEN OUT OF THE BODY BY SNARING THEM. NO ADVERSE OUTCOMES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923458 ↗
• MalfunctionMar 21, 2025Failure to Advance; Failure to Advance

  N/A.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660202 ↗

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