iCast Covered Stent System, 7mmX22mmX120cm 42722Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862427226), received between Aug 8, 2024 and Apr 13, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Activation Failure

  IT WAS REPORTED THAT DURING VISCERAL AORTIC ANEURYSM REPAIR, THE BALLOON DID NOT FULLY INFLATE AFTER ACHIEVING NOMINAL BALLOON PRESSURE OF 4¿6 ATM, RESULTING IN INCOMPLETE STENT EXPANSION. THE DISTAL AND PROXIMAL ENDS EXPANDED, WHILE THE MID-PORTION REMAINED UNDEREXPANDED. THE STENT WAS SUCCESSFULLY POST-DILATED WITH A SEPARATE BALLOON, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855204 ↗
• MalfunctionMar 30, 2026Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727819 ↗
• MalfunctionNov 7, 2025Off-Label Use; Device Fell; Off-Label Use; Device Fell

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497875 ↗
• 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 23497874 ↗
• MalfunctionJun 17, 2025Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE INTENDED TARGET FOR STENTING WAS THE SMA, VIA RIGHT COMMON FEMORAL ARTERY, HOWEVER SIGNIFICANT CALCIFICATION WAS OBSERVED NEAR THE VESSEL ORIGIN. THE VESSEL WAS UNABLE TO BE PRE-DILATED WITH A 7MM BOSTON SCIENTIFIC MUSTANG DILATION CATHETER DUE TO THE CALCIFICATION. THE PHYSICIAN STILL ATTEMPTED MULTIPLE TIMES TO ADVANCE THE ICAST STENT, BUT IT WOULD NOT TRACK PAST THE CALCIFICATION. WHILE REMOVING THE UNDEPLOYED ICAST STENT OVER THE WIRE, THE STENT BECAME STUCK WITHIN THE VALVE OF THE SHEATH. THE REMAINDER OF THE ICAST CATHETER WAS SUCCESSFULLY WITHDRAWN OVER THE WIRE. THE SHEATH AND STENT WERE REMOVED TOGETHER AS A SINGLE UNIT AND IT WAS CONFIRMED THAT THE ENTIRE STENT WAS INTACT AND THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. THERE WAS NO HARM REPORTED. THE VESSEL WAS ABLE TO BE PRE-DILATED WITH A SMALLER BOSTON MUSTANG, AND A SECOND ICAST STENT WAS THEN DEPLOYED SUCCESSFULLY COMPLETING THE PROCEDURE WITHOUT FURTHER COMPLICATION.

  Patient problems: Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238012 ↗
• MalfunctionApr 25, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909385 ↗
• MalfunctionJan 15, 2025Positioning Problem; Positioning Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164673 ↗
• MalfunctionAug 8, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942864 ↗

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