Nalu Medical, Inc. is recalling 13 units of its Neurostimulation and Peripheral Nerve Stimulation Kits because a manufacturing defect may cause the implanted device to stop working. This defect reduces the efficiency of the radiofrequency signals between the internal pulse generator and the external therapy disc, rendering the system unable to block pain signals. Affected kits were distributed in Missouri, Illinois, California, Texas, Tennessee, Oklahoma, Arizona, and Arkansas.
If the device becomes non-functional, it will no longer inhibit the transmission of pain signals to the brain, leading to a return of chronic pain symptoms. Patients may require additional medical intervention or surgical replacement of the implanted pulse generator if the system fails.
Healthcare provider notification and manufacturer consultation.
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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