Recall Z-1592-2021— Boston Scientific Corporation
Class I · Ongoing
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2021-04-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The firm has received reports of stent migration after implantation.
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-04-12
- Firm location
- Maple Grove, MN, United States
Product description
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.
Reason for recall
The firm has received reports of stent migration after implantation
Data sourced from openFDA. This site is unofficial and independent of the FDA.