Deep brain stimulation burr hole kits recalled over retaining clip closing resistance
Burr Hole Cover Kits used with the Vercise Deep Brain Stimulation System are recalled because resistance closing the retaining clip may cause procedural delay or lead migration requiring further surgery. 24,583 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes possible lead migration requiring additional surgery and reports no injuries.
Plain-English summary
The Burr Hole Cover Kit, REF M365DB4600C0, and the Burr Hole Cover Spares Kit, REF M365DB4605C0, are being recalled across all lots. They are components of the Vercise Deep Brain Stimulation System used with the Surgical Implant Manual. The recall covers 24,583 units distributed in the United States and worldwide.
Resistance and difficulty could occur while closing the retaining clip locking mechanism that forms part of the burr hole cover kit. The manufacturer states this may lead to procedural delay, or to lead migration, which may require additional surgery. The FDA classified the action as Class II.
Hospitals and surgical teams should follow the manufacturer's updated instructions for the affected kits. Patients with an implanted system should raise any questions with their treating neurologist or neurosurgeon.
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
- locking-mechanism
- lead-migration
- deep-brain-stimulation
- class-ii
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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