Class 1 Device Recall VICI VENOUS STENT System

• Date Initiated by Firm: April 12, 2021
• Create Date: May 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1592-2021
• Recall Event ID: 87721
• PMA Number: P180013
• Product Classification: Stent, iliac vein - Product Code QAN
• Product: 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.
• Code Information: all batches/lots of the device manufactured between May 2018 through April 2021
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Rebecca KinKead Rubio; 763-494-1700
• Manufacturer Reason for Recall: The firm has received reports of stent migration after implantation
• FDA Determined 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 in Commerce: 34,248 units
• Distribution: Worldwide - US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = QAN