FDA Device recall Z-2558-2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 by Boston Scientific Neuromodulation, citing wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful sti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2558-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-08 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Reason
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 requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.
Identifiers
| code_info | UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A |
|---|
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-2558-2025%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.