Z-1592-2021Class I

VICI RDS VENOUS STENT System

Name: Z-1592-2021 VICI RDS VENOUS STENT System
Creator: Boston Scientific Corporation
Published: 2021-04-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-04-12 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous... on 2021-04-12. FDA classified it as Class I and gives the reason as "The firm has received reports of stent migration after implantation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1592-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-04-12
Posted: 2021-05-19
Recalling firm: Boston Scientific Corporation
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.
Product code: QAN Stent, Iliac Vein
Reason for recall: The firm has received reports of stent migration after implantation
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 34,248 units
Distribution: Worldwide - US Nationwide Distribution
Product codes and lots: all batches/lots of the device manufactured between May 2018 through April 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1592-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1591-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1592-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-19

Product code QAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)