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U.S. Department of Health and Human Services

Class 1 Device Recall VICI VENOUS STENT System

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  Class 1 Device Recall VICI VENOUS STENT System see related information
Date Initiated by Firm April 12, 2021
Create Date May 19, 2021
Recall Status1 Open3, 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 2		 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 and Original Applicant = Boston Scientific Corporation
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