Recall Z-1592-2021 ยท QAN Stent, Iliac Vein
Boston Scientific Corporation
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
| Date | Apr 12, 2021 |
| Status | Open, Classified |
| Reason | The firm has received reports of stent migration after implantation |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific initiated the recall by letter on April 12, 2021. The letter requested the consignee cease use and further distribution of the affected product, segregate and return to Boston Scientific. Distributors were directed to further distribute the notice to their customers. For questions contact your local Sales Representative. |
| Quantity | 34,248 units |
| Distribution | Worldwide - US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.