Reported Aug 27, 2025 · Ongoing
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep…
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- Burr Hole Cover Kit
- REFM365DB4600C0; Burr Hole Cover Spares Kit
- REFM365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
- Lot codes and dates
- All lots. Surgical
- Implant Manual version REF/UDI-DI
M365DB4600C0/08714729820802M365DB4605C0/08714729820819
- Amount recalled
- 24,583
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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