Use cautionMedical device recall · FDA · Published April 12, 2021
Boston Scientific VICI Venous Stent Recall: Stent Migration Risk
Boston Scientific recalls VICI Venous Stent System (May 2018-April 2021) due to reported stent migration after implantation. Affected patients should consult their doctor for evaluation.
“Boston Scientific VICI Venous Stent Recall: Stent Migration Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62795-boston-scientific-vici-venous-stent-recall-stent-migration-risk. Based on FDA recall #Z-1591-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2021%22&limit=1).
Boston Scientific Corporation recalled the VICI VENOUS STENT System worldwide on April 12, 2021, according to the FDA. The Class I recall affects all units manufactured between May 2018 and April 2021 due to reports of stent migration after implantation.
How to tell if you have it
Brand: Boston Scientific
Product: VICI VENOUS STENT System
Manufacture dates: May 2018 through April 2021
Quantity: 550 units
The hazard
The firm has received reports of stent migration after implantation. The device is intended for the treatment of obstructions and occlusions in the venous vasculature.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls include the Boston Scientific Imager II Angiographic Catheters Recall (August 24, 2026) and the Boston Scientific LUX-Dx Cardiac Monitor System Recall (August 6, 2026). Similar product recalls include the Medtronic Abre Venous Stent Recall (December 4, 2025), the Bolton Medical RelayPro Thoracic Stent-Graft System Recall (April 22, 2026), and the Microvention LVIS Stent Device Recall (April 6, 2026).
How to tell if you have this one
Check if you received the VICI Venous Stent System manufactured between May 2018 and April 2021. The product is used for treating venous obstructions and occlusions.
Brand
Boston Scientific
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Worldwide - US Nationwide Distribution
Recall number
Product, codes & lots
Quantity
Z-1591-2021
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.; all batches/lots of the device manufactured between May 2018 through April 2021
550 units
Z-1592-2021
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.; all batches/lots of the device manufactured between May 2018 through April 2021
34,248 units
Based on the official FDA remedy
What to do — step by step
Consult Your Doctor
Contact your healthcare provider to discuss potential stent migration and necessary follow-up procedures.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1591-2021 (April 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1591-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.