PMA · Approved
Recalled · Class I · 2025Carotid Wallstent Monorail Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NIM Stent, Carotid
Approved on Oct 23, 2008 through premarket approval, which rests on the device’s own clinical evidence after a 1,248-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 23, 2008
- Review
- 1,248 days
- Class
- Class III
- Product code
- NIM
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050019 has 41 supplements since 2009: 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 |
|---|---|
| 2009 | 1 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 7 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 1 |
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 |
|---|---|---|---|---|
| Jul 7, 2025 | Class I | Z-2273-2025 | Process change control | Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIM devicesNIM Stent, Carotid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NIM
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIM
Too few NIM 510(k)s in any year since 2007 to give a median.
Recalls per year · NIM
7so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIM
581in 2025
MAUDE reports naming product code NIM, 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 | 24 | — | 1 | 493 |
| 2008 | 19 | — | 1 | 790 |
| 2009 | 12 | — | 3 | 961 |
| 2010 | 14 | — | 3 | 1,039 |
| 2011 | 17 | — | 0 | 720 |
| 2012 | 23 | — | 0 | 560 |
| 2013 | 14 | — | 0 | 469 |
| 2014 | 2 | — | 2 | 201 |
| 2015 | 11 | — | 0 | 127 |
| 2016 | 11 | — | 0 | 121 |
| 2017 | 8 | — | 0 | 133 |
| 2018 | 12 | — | 0 | 103 |
| 2019 | 11 | — | 1 | 181 |
| 2020 | 7 | — | 0 | 164 |
| 2021 | 13 | — | 0 | 202 |
| 2022 | 17 | — | 0 | 172 |
| 2023 | 14 | — | 0 | 172 |
| 2024 | 21 | — | 0 | 265 |
| 2025 | 24 | — | 1 | 581 |
| 2026 | 17 | — | 7 | — |
https://510kreport.com/device/P050019 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050019: Carotid Wallstent Monorail Endoprosthesis.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050019
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026