Stent, Iliac Vein
FDA product code QAN · Class III (high risk) · Cardiovascular
A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
0510(k) clearances
5PMA approvals
9recalls
Implantimplanted device
PMA approvals
- P230021 Duo Venous Stent System · Philips Image Guided Therapy Corporation · 12/26/2023
- P200026 Abre Venous Self-expanding Stent System · Medtronic Vascular, Inc. · 10/21/2020
- P200023 Zilver Vena Venous Self-Expanding Stent · Cook Ireland, Ltd. · 10/09/2020
- P180013 VICI VENOUS STENT System · Boston Scientific Corporation · 05/02/2019
- P180037 Venovo Venous Stent System · Bard Peripheral Vascular, Inc. · 03/13/2019
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1098-2026 Class II | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090…Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and… | Medtronic Inc | 12/04/2025Open, Classified |
| Z-1317-2024 Class II | Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b)…There is a potential for sterile package breach. | Medtronic Inc. | 02/16/2024Open, Classified |
| Z-0464-2022 Class II | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding…There have been reports of stent migration. | Medtronic Inc., Cardiac Rhythm and Heart… | 11/19/2021Terminated |
| Z-1592-2021 Class I | VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter…The firm has received reports of stent migration after implantation | Boston Scientific Corporation | 04/12/2021Open, Classified |
| Z-1591-2021 Class I | VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions…The firm has received reports of stent migration after implantation | Boston Scientific Corporation | 04/12/2021Open, Classified |
| Z-1532-2021 Class II | Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 -…Incorrect size printed on the device; packaging is labeled correctly. | Medtronic Inc. | 03/16/2021Terminated |
| Z-1899-2021 Class II | VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… | Bard Peripheral Vascular Inc | 12/14/2020Open, Classified |
| Z-1898-2021 Class II | VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… | Bard Peripheral Vascular Inc | 12/14/2020Open, Classified |
| Z-1897-2021 Class II | VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… | Bard Peripheral Vascular Inc | 12/14/2020Open, Classified |