VICI VENOUS STENT System Product Usage: is intended for the treatment… — Class I medical device recall Z-1591-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-05-26, distributed nationwide. The firm has received reports of stent migration after implantation
| Recall number | Z-1591-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2021-04-12 |
| Classified | 2021-05-19 |
| Reported by FDA | 2021-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 550 units |
Product
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Reason for recall
The firm has received reports of stent migration after implantation
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1591-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.