VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
- Company
- Boston Scientific Corporation
- Recall Initiated
- April 12, 2021
- Recall Number
- Z-1591-2021
- Quantity
- 550 units
- Firm Location
- Maple Grove, MN
Reason for Recall
The firm has received reports of stent migration after implantation
Distribution
Worldwide - US Nationwide Distribution
Lot / Code Info
all batches/lots of the device manufactured between May 2018 through April 2021
Root Cause
Under Investigation by firm
Action Taken
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.
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