Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Burr Hole Cover Kit Recalled by Boston Scientific Neuromodulation Corporation Due to Resistance and difficulties could occur while closing the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Neuromodulation Corporation directly.
Affected Products
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
Quantity: 24,583
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Neuromodulation Corporation
Boston Scientific Neuromodulation Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report