Medtronic Neuromodulation is recalling 39 units of the Percept RC Implantable Neurostimulator (INS), Model B35300. This recall was initiated because these specific devices are unable to communicate with the A610 DBS Clinician Programmer Application during use. When doctors or clinicians attempt to program the device, they will receive an "Invalid Device" error message. Consumers with these implanted devices should contact their healthcare provider or Medtronic for further instructions regarding the device's functionality and potential next steps.
The device failure prevents medical professionals from communicating with or adjusting the neurostimulator's settings, which can lead to an inability to manage the patient's symptoms effectively. No injuries have been reported to date, but the communication error renders the device's specialized programming features inaccessible.
Consultation with healthcare provider
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.