Iliac Covered Stent, Arterial
FDA product code PRL · Class III (high risk) · Cardiovascular
For the treatment of de novo or restenotic lesions found in iliac arteries
0510(k) clearances
3PMA approvals
6recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0024-2025 Class II | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. | Atrium Medical Corporation | 09/09/2024Open, Classified |
| Z-2946-2024 Class II | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following…Due to packaging defects, sterility assurance and heparin activity may be compromised. | W L Gore & Associates, Inc. | 07/01/2024Open, Classified |
| Z-2945-2024 Class II | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following…Due to packaging defects, sterility assurance and heparin activity may be compromised. | W L Gore & Associates, Inc. | 07/01/2024Open, Classified |
| Z-0291-2024 Class II | Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for…Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. | Atrium Medical Corporation | 09/21/2023Open, Classified |
| Z-0077-2022 Class II | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59…Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may… | W L Gore & Associates, Inc. | 09/07/2021Open, Classified |
| Z-0718-2020 Class II | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X…Certain product code/lot number combinations may experience introducer sheath compatibility issues when used… | Bard Peripheral Vascular Inc | 02/18/2019Terminated |