Burr Hole Cover Kit — Class II medical device recall Z-2340-2025
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2025-08-27, distributed nationwide. Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a
| Recall number | Z-2340-2025 |
|---|---|
| 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 | 2025-08-19 |
| Reported by FDA | 2025-08-27 |
| 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, TW, UA, ZA |
| Quantity | 24,583 |
| UPC / GTIN / UDI-DI | 08714729820802, 08714729820819 |
| Model numbers | M365DB4600C0, M365DB4605C0 |
Product
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Reason for recall
Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.
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-2340-2025. 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.