Boston Scientific recalls Burr Hole Cover Kits (REF: M365DB4600C0 and M365DB4605C0) for potential procedure delays or additional surgery due to locking mechanism issues in Deep Brain Stimulation systems.
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.
Boston Scientific is recalling two burr hole cover kits used with their Vercise Deep Stimulation System. The kits may cause procedure delays or require additional surgery if the locking mechanism doesn't close properly.
The burr hole cover kit's retaining clip locking mechanism may not close properly during surgery. This could cause procedural delays or lead to lead-migration, requiring additional surgery to fix the issue.
Patients who have received the Vercise Deep Stimulation System surgery with these specific burr hole cover kits are affected. Those with the kits may need additional surgery if the locking mechanism fails during procedures.
Check if your Vercise Deep Stimulation System includes the Burr Hole Cover Kit with REF: M365DB4600C0 or Burr Hole Cover Spares Kit with REF: M365DB4605C0. These kits were used with the Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802 or M365DB4605C0/08714729820819.
Identify if your Vercise Deep Stimulation System includes the Burr Hole Cover Kit (REF: M365DB4600C0) or Burr Hole Cover Spares Kit (REF: M365DB4605C0).
No, but you should check if you have the recalled kits and contact Boston Scientific if you're concerned about procedure delays or additional surgery.
The hazard could cause procedural delays or lead-migration, which may require additional surgery to fix the issue.
Check your Vercise Deep Stimulation System for the Burr Hole Cover Kit with REF: M365DB4600C0 or Burr Hole Cover Spares Kit with REF: M365DB4605C0, as listed in the Surgical Implant Manual version references.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2340-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2340-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
