Abbott Medical is recalling approximately 196,612 Proclaim series Implantable Pulse Generators because the time between the 'elective replacement indicator' (low battery warning) and the actual end of service may be shorter than what is stated in the product labeling. This affects various models including the Proclaim XR, Proclaim Plus, and Proclaim Elite systems. Consumers with these implanted devices may experience a sudden loss of therapy sooner than expected once the replacement warning is triggered. You should contact your healthcare provider or Abbott Medical to discuss how this affects your device management and replacement schedule.
If the device reaches its end of service earlier than expected, patients may experience an unexpected loss of stimulation therapy, which could lead to a recurrence of symptoms or require an unplanned surgical procedure to replace the generator sooner than anticipated.
Healthcare provider notification and monitoring
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
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