—#186850

Product

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

FDA product code: QAN — Stent, Iliac Vein
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P180013
Affected lot / code info: all batches/lots of the device manufactured between May 2018 through April 2021

Why it was recalled

The firm has received reports of stent migration after implantation

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide - US Nationwide Distribution

Timeline

Recall initiated: 2021-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186850. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.