Boston Scientific Neuromodulation Corporation is recalling 24,583 Burr Hole Cover Kits and Spares Kits used as components of the Vercise Deep Brain Stimulation (DBS) System. The retaining clip locking mechanism on these kits may be difficult or impossible to close properly during surgical procedures. This defect can lead to delays during surgery or cause the implanted lead to move out of place after the operation, which may require patients to undergo additional surgery to correct.
A faulty locking mechanism may fail to secure the brain lead, causing it to migrate. If the lead moves, the system may not work correctly, potentially requiring follow-up surgery to reposition the hardware.
Component of Vercise Deep Stimulation System used with the Surgical Implant Manual
Component of Vercise Deep Stimulation System used with the Surgical Implant Manual
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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