Drug recall
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and…
FDA recall event 94377 · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Event ID | 94377 |
|---|---|
| Recall numbers | Z-1890-2024 |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Product type | Devices |
| Products | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 18, 2024 |
| Report date | Jun 5, 2024 |
| 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: