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FDA Labels Inspire Medical's Sleep Apnea Nerve Stimulator Recall As Most Serious

The FDA has labeled a recall of Inspire Medical Systems, Inc.’s (NYSE:INSP) nerve-stimulating implant for obstructive sleep apnea as Class I, the most serious kind. Inspire initiated a recall of its IV Implantable Pulse Generator (IPG) on June 17. The recall extends to 32 devices of the Model 3028 IPG. Inspire Medical Systems is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect. The defect can cause system malfunctions after implantation, leading to electrical leakage in the ...