Medtronic has issued a recall for approximately 18,010 neuromodulation devices, including Activa SC and Percept neurostimulators and associated pocket adaptors. The recall is due to a finding that patients implanted with specific pocket adaptors (Models 64001 and 64002) are restricted to 'Head Only' MRI eligibility rather than full-body scans. Consumers who have these devices should contact their healthcare provider or Medtronic directly to discuss how this affects future medical imaging.
Using these devices during a full-body MRI scan when they are only rated for head scans could cause the implanted hardware to overheat or malfunction, potentially resulting in tissue damage or loss of therapy. No specific injuries or deaths were reported in the provided data.
Patient and Record Updates
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 · 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.