Burr Hole Cover Kit Recall Due to Retaining Clip Closure Difficulty
Boston Scientific is recalling Burr Hole Cover Kits used in Vercise Deep Brain Stimulation systems. The retaining clip locking mechanism may be difficult to close during surgery, potentially causing procedural delays or requiring additional surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with potential for serious harm (lead migration requiring surgery), but no reported illnesses or injuries to date. Per the rubric, this qualifies as 'High' severity—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling Burr Hole Cover Kits (REF: M365DB4600C0) and Burr Hole Cover Spares Kits (REF: M365DB4605C0), which are components of the Vercise Deep Brain Stimulation (DBS) system used during surgical brain implantation. Approximately 24,583 units have been distributed worldwide.
The retaining clip locking mechanism in these kits may experience resistance and difficulties when closing during surgical procedures. This malfunction could result in procedural delays or lead migration, which may require additional surgery.
The kits were distributed worldwide, including throughout the United States and in numerous countries spanning Europe, Asia, the Middle East, Africa, and the Americas.
Healthcare providers and patients with existing DBS implants placed using these kits should contact Boston Scientific or their treating medical center for guidance. The FDA and manufacturer recommend verifying affected inventory and following all manufacturer guidance on management of these devices.
The recalled product
- 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
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Hazard
- closure-difficulty
- lead-migration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- M365DB4605C0/08714729820819
Distribution
Distributed nationwide across the United States.
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