iCast Covered Stent System, 6mmX16mmX120cm 42616Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00650862426168), received between Jul 20, 2024 and May 20, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 9, 2024Class IIOpen, Classified

   There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

   Z-0024-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Premature Separation

  IT WAS REPORTED THAT WHILE PULLING BACK THE ICAST STENT DEVICE INTO THE GORE VBX, THE STENT PARTIALLY DISLODGED FROM THE BALLOON. THE PHYSICIAN BALLOONED THE STENT UP, AND IT WAS SUCCESSFULLY IMPLANTED WITH NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228758 ↗
• MalfunctionNov 21, 2025Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615107 ↗
• InjuryJun 13, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201234 ↗
• MalfunctionJul 22, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  REPORT RECEIVED FROM DISTRIBUTOR STATED THAT THE PRODUCT LABELING WAS FOUND TO HAVE AN ERROR. THE PRODUCT DATE OF MANUFACTURE WAS LISTED IN THE DISTRIBUTOR UDI BARCODE LABEL INSTEAD OF THE EXPIRATION DATE OF THE PRODUCT. THE EXPIRATION DATE ON THE PRIMARY MANUFACTURER PRODUCT LABEL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802132 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787634 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  REPORT RECEIVED FROM DISTRIBUTOR STATED THAT THE PRODUCT LABELING WAS FOUND TO HAVE AN ERROR. THE PRODUCT DATE OF MANUFACTURE WAS LISTED IN THE DISTRIBUTOR UDI BARCODE LABEL INSTEAD OF THE EXPIRATION DATE OF THE PRODUCT. THE EXPIRATION DATE ON THE PRIMARY MANUFACTURER PRODUCT LABEL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787633 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  REPORT RECEIVED FROM DISTRIBUTOR STATED THAT THE PRODUCT LABELING WAS FOUND TO HAVE AN ERROR. THE PRODUCT DATE OF MANUFACTURE WAS LISTED IN THE DISTRIBUTOR UDI BARCODE LABEL INSTEAD OF THE EXPIRATION DATE OF THE PRODUCT. THE EXPIRATION DATE ON THE PRIMARY MANUFACTURER PRODUCT LABEL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787632 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787631 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787630 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  REPORT RECEIVED FROM DISTRIBUTOR STATED THAT THE PRODUCT LABELING WAS FOUND TO HAVE AN ERROR. THE PRODUCT DATE OF MANUFACTURE WAS LISTED IN THE DISTRIBUTOR UDI BARCODE LABEL INSTEAD OF THE EXPIRATION DATE OF THE PRODUCT. THE EXPIRATION DATE ON THE PRIMARY MANUFACTURER PRODUCT LABEL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787629 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787628 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  REPORT RECEIVED FROM DISTRIBUTOR STATED THAT THE PRODUCT LABELING WAS FOUND TO HAVE AN ERROR. THE PRODUCT DATE OF MANUFACTURE WAS LISTED IN THE DISTRIBUTOR UDI BARCODE LABEL INSTEAD OF THE EXPIRATION DATE OF THE PRODUCT. THE EXPIRATION DATE ON THE PRIMARY MANUFACTURER PRODUCT LABEL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787627 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787626 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  REPORT RECEIVED FROM DISTRIBUTOR STATED THAT THE PRODUCT LABELING WAS FOUND TO HAVE AN ERROR. THE PRODUCT DATE OF MANUFACTURE WAS LISTED IN THE DISTRIBUTOR UDI BARCODE LABEL INSTEAD OF THE EXPIRATION DATE OF THE PRODUCT. THE EXPIRATION DATE ON THE PRIMARY MANUFACTURER PRODUCT LABEL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787625 ↗
• MalfunctionJul 20, 2024Expiration Date Error; Inaccurate Information; Expiration Date Error; Inaccurate Information

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787624 ↗

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