Vercise Deep Brain Stimulation Systems Surgical Implant Manual — Class II medical device recall Z-2558-2025
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2025-09-24, distributed nationwide. Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in
| Recall number | Z-2558-2025 |
|---|---|
| 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 | 2025-07-08 |
| Classified | 2025-09-12 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BG, BR, CA, CH, CL, CN, CO, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, LB, LU, MA, MT, MX, NL, NO, PK, PL, PT, RO, RS, SA, SE, SG, SK, TH, TW, UA, ZA |
| Quantity | 25,260 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08714729985044, 08714729985051 |
Product
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
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 requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.
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-2558-2025. 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.