PMA · Approved
Recalled · Class I · 2021VICI VENOUS STENT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · QAN Stent, Iliac Vein
Approved on May 2, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 371-day review. It has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- May 2, 2019
- Review
- 371 days
- Class
- Class III
- Product code
- QAN
- Recalls
- 2 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P180013 has 7 supplements since 2019: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2021 | Class I | Z-1592-2021 | Under Investigation by firm | The firm has received reports of stent migration after implantation |
| Apr 12, 2021 | Class I | Z-1591-2021 | Under Investigation by firm | The firm has received reports of stent migration after implantation |
No ancestor or descendant has a Class I recall.
How does its category compare?
All QAN devicesQAN Stent, Iliac Vein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QAN
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAN
Too few QAN 510(k)s in any year since 2007 to give a median.
Recalls per year · QAN
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAN
177in 2025
MAUDE reports naming product code QAN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | — | 0 | 24 |
| 2020 | 10 | — | 0 | 117 |
| 2021 | 11 | — | 1 | 425 |
| 2022 | 5 | — | 0 | 115 |
| 2023 | 7 | — | 0 | 208 |
| 2024 | 9 | — | 0 | 128 |
| 2025 | 5 | — | 0 | 177 |
| 2026 | 8 | — | 0 | — |
https://510kreport.com/device/P180013 · printed Nov 6, 2026
Cite this page
510(k) Report. “P180013: VICI VENOUS STENT System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P180013
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026