FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: 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.
- Recall number
- Z-1592-2021
- 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.
- Status
- Open, Classified
- Initiated
- 2021-04-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm has received reports of stent migration after implantation
- 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
- 34,248 units
- Distribution
- Worldwide - US Nationwide Distribution
- Lot, serial or model codes
- all batches/lots of the device manufactured between May 2018 through April 2021
- 510(k) numbers
- not on file
- PMA numbers
- ["P180013"]
- Product code
- QAN
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28