FDA Device recall Z-1890-2024
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 by Boston Scientific Neuromodulation, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1890-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Reason
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.
Identifiers
| code_info | REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365DB12160/8714729985044/100209 - 753347/09-OCT-2020 throu…REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365DB12160/8714729985044/100209 - 753347/09-OCT-2020 through 26-MAR-2026; M365DB12320/8714729985051/100104 - 753200/09-OCT-2020 through 21-MAR-2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.