Recall Z-1591-2021— 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 VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.. 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 VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
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.