FDA Device recall Z-1592-2021
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of sympt…
- FDA Device
- Class I
- ongoing
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class I recall of VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of sympt… 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-1592-2021 |
| 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 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
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-1592-2021%22
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