FDA Device recall Z-1591-2021
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature
- FDA Device
- Class I
- ongoing
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class I recall of VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature by Boston Scientific, citing the firm has received reports of stent migration after implantation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1591-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-04-12 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
Identifiers
| code_info | all batches/lots of the device manufactured between May 2018 through April 2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2021%22
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