Vercise Genus Deep Brain Stimulation — Class II medical device recall Z-1890-2024
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2024-06-05, distributed nationwide. Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG
| Recall number | Z-1890-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2024-04-18 |
| Classified | 2024-05-24 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CO, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, HU, IE, IN, IS, IT, JO, JP, KR, LU, MT, NL, NO, PL, PT, RS, SA, SE, SG, SK, TH, TR, UA |
| Quantity | 14,977 |
| UPC / GTIN / UDI-DI | 08714729985044, 08714729985051 |
| Model numbers | M365DB12160, M365DB12320, R32IPG |
Product
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
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 stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1890-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.