PMA · Approved
Recalled · Class II · 2025Vercise Deep Brain Stimulation (DBS)System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
Approved on Dec 8, 2017 through premarket approval, which rests on the device’s own clinical evidence after an 835-day review. It has been recalled 4 times.
- Decided
- Dec 8, 2017
- Review
- 835 days
- Class
- Class III
- Product code
- NHL
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150031 has 94 supplements since 2018: 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 |
|---|---|
| 2018 | 6 |
| 2019 | 17 |
| 2020 | 11 |
| 2021 | 9 |
| 2022 | 6 |
| 2023 | 12 |
| 2024 | 14 |
| 2025 | 9 |
| 2026 | 10 |
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 NHL? 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 8, 2025 | Class II | Z-2340-2025 | Component change control | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or… |
| Jul 8, 2025 | Class II | Z-2558-2025 | Labeling design | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and… |
| Apr 18, 2024 | Class II | Z-1890-2024 | Device Design | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience… |
| Apr 24, 2019 | Class II | Z-2125-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NHL devicesNHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NHL
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHL
Too few NHL 510(k)s in any year since 2007 to give a median.
Recalls per year · NHL
No recall names NHL since 2007.
Adverse event reports per year · NHL
197in 2025
MAUDE reports naming product code NHL, 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 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 6 | — | 0 | 66 |
| 2019 | 17 | — | 0 | 74 |
| 2020 | 11 | — | 0 | 146 |
| 2021 | 8 | — | 0 | 205 |
| 2022 | 6 | — | 0 | 214 |
| 2023 | 12 | — | 0 | 411 |
| 2024 | 14 | — | 0 | 396 |
| 2025 | 10 | — | 0 | 197 |
| 2026 | 10 | — | 0 | — |
https://510kreport.com/device/P150031 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150031: Vercise Deep Brain Stimulation (DBS)System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150031
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026