# P150031: Vercise Deep Brain Stimulation (DBS)System

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Dec 8, 2017 after 835 days
- Product code: NHL (Stimulator, Electrical, Implanted, For Parkinsonian Symptoms)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 8, 2025 · Class II · Z-2340-2025: 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 le
- Jul 8, 2025 · Class II · Z-2558-2025: 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 requir
- Apr 18, 2024 · Class II · Z-1890-2024: 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 stim
- Apr 24, 2019 · Class II · Z-2125-2020: 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 lab

Source page: https://510kreport.com/device/P150031
Methodology: https://510kreport.com/methodology