Boston Scientific Corporation Recall 87721
Description: VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Boston Scientific Corporation Recall 87721 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1591-2021 |
Event ID | 87721 |
Event Description | VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature. |
Product Type | Devices |
Distribution | Worldwide - US Nationwide Distribution |
Quantity | 550 units |
Recall Reason | The firm has received reports of stent migration after implantation |
Device Classification | 20210526 |
Device Code Info | all batches/lots of the device manufactured between May 2018 through April 2021 |
Center Classification Date | 20210519 |
Recall Initiation Date | 20210412 |
Recalling Firm | Boston Scientific Corporation |
Initial Notification | Letter |
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