FDA Device recall Z-2340-2025
Burr Hole Cover Kit, REF: M365DB4600C0
- FDA Device
- Class II
- ongoing
- Published 2025-08-27
On 2025-08-27 the FDA classified a Class II recall of Burr Hole Cover Kit, REF: M365DB4600C0 by Boston Scientific Neuromodulation, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2340-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-08 |
| Published | 2025-08-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819 |
|---|
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-2340-2025%22
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