PMA · Approved
Recalled · Class II · 2022Woven EndoBridge (WEB) Aneurysm Embolization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · OPR Intrasaccular Flow Disruption Device
Approved on Dec 31, 2018 through premarket approval, which rests on the device’s own clinical evidence after a 459-day review. It has been recalled once.
- Decided
- Dec 31, 2018
- Review
- 459 days
- Class
- Class III
- Product code
- OPR
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P170032 has 20 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 | 1 |
| 2020 | 3 |
| 2021 | 6 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2026 | 3 |
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.
Planning a device in OPR? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2022 | Class II | Z-0170-2023 | Process control | Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OPR devicesOPR Intrasaccular Flow Disruption Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OPR
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OPR
Too few OPR 510(k)s in any year since 2007 to give a median.
Recalls per year · OPR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OPR
218in 2025
MAUDE reports naming product code OPR, 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 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 21 |
| 2020 | 3 | — | 0 | 11 |
| 2021 | 6 | — | 0 | 59 |
| 2022 | 1 | — | 1 | 62 |
| 2023 | 3 | — | 0 | 119 |
| 2024 | 3 | — | 0 | 262 |
| 2025 | 0 | — | 0 | 218 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P170032 · printed Nov 6, 2026
Cite this page
510(k) Report. “P170032: Woven EndoBridge (WEB) Aneurysm Embolization System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P170032
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026