Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

FDA Recall Z-1591-2021 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeQAN
Date Initiated2021-04-12
Product Quantity550 units

Reason for Recall

The firm has received reports of stent migration after implantation

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑