PMA · Approved
Recalled · Class II · 2024Axonics Sacral Neuromodulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · EZW Stimulator, Electrical, Implantable, For Incontinence
Approved on Nov 13, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 342-day review. It has been recalled once.
- Decided
- Nov 13, 2019
- Review
- 342 days
- Class
- Class III
- Product code
- EZW
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P180046 has 103 supplements since 2020: 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 |
|---|---|
| 2020 | 21 |
| 2021 | 15 |
| 2022 | 15 |
| 2023 | 14 |
| 2024 | 15 |
| 2025 | 9 |
| 2026 | 14 |
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 EZW? 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 |
|---|---|---|---|---|
| Jul 15, 2024 | Class II | Z-0198-2027 | Component change control | Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All EZW devicesEZW Stimulator, Electrical, Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EZW
36in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZW
Too few EZW 510(k)s in any year since 2007 to give a median.
Recalls per year · EZW
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZW
6,956in 2025
MAUDE reports naming product code EZW, 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 | 6 | — | 2 | 168 |
| 2008 | 14 | — | 1 | 724 |
| 2009 | 12 | — | 0 | 1,012 |
| 2010 | 24 | — | 0 | 1,425 |
| 2011 | 26 | — | 0 | 1,610 |
| 2012 | 19 | — | 0 | 2,815 |
| 2013 | 17 | — | 0 | 3,736 |
| 2014 | 23 | — | 0 | 4,603 |
| 2015 | 20 | — | 0 | 5,977 |
| 2016 | 27 | — | 0 | 7,083 |
| 2017 | 27 | — | 0 | 8,097 |
| 2018 | 19 | — | 0 | 5,737 |
| 2019 | 24 | — | 0 | 4,772 |
| 2020 | 43 | — | 0 | 4,118 |
| 2021 | 34 | — | 1 | 4,479 |
| 2022 | 46 | — | 1 | 4,318 |
| 2023 | 32 | — | 0 | 5,056 |
| 2024 | 35 | — | 1 | 5,773 |
| 2025 | 36 | — | 0 | 6,956 |
| 2026 | 37 | — | 1 | — |
https://510kreport.com/device/P180046 · printed Nov 6, 2026
Cite this page
510(k) Report. “P180046: Axonics Sacral Neuromodulation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P180046
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026