Drug recall
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
FDA recall event 97144 · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Event ID | 97144 |
|---|---|
| Recall numbers | Z-2558-2025 |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Product type | Devices |
| Products | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jul 8, 2025 |
| Report date | Sep 24, 2025 |
| City | Valencia |
| State | CA |
| Country | United States |
| FEI number | 3006630150 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: