PMA · Approved
Recalled · 2010Acculink Carotid Stent System and RX Acculink Carotid Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular · NIM Stent, Carotid
Approved on Aug 30, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 168-day review. It has been recalled 4 times.
- Decided
- Aug 30, 2004
- Review
- 168 days
- Class
- Class III
- Product code
- NIM
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040012 has 64 supplements since 2004: 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 |
|---|---|
| 2004 | 1 |
| 2006 | 20 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 7 |
| 2012 | 9 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2020 | 1 |
| 2021 | 3 |
| 2023 | 1 |
| 2025 | 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.
Planning a device in NIM? 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 10, 2010 | Not classified | Z-0337-2011 | Pending | The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may… |
| Sep 10, 2010 | Not classified | Z-0338-2011 | Pending | The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may… |
| Sep 10, 2010 | Not classified | Z-0339-2011 | Pending | The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may… |
| Oct 1, 2009 | Not classified | Z-0749-2010 | Process control | The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength. |
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.
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/P040012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040012: Acculink Carotid Stent System and RX Acculink Carotid Stent System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026