FDA Slaps Boston Scientific Corporation’s Recall of 500 Innova Stents with Class I Status

Boston Scientific Corp. Boston Scientific Corp. Follow this company has recalled more than 500 stent systems in its second recall for a potentially life-threatening defect to be disclosed this week. The stent may fail to deploy or partially deploy, the company said. A partial deployment could injure vessel walls or necessitate emergency surgery. Natick, Mass.-based Boston Scientific (NYSE: BSX), which has large operations in Maple Grove and Arden Hills, said the affected products are Innova Over-the-Wire Self-Expanding stent systems. They are used to treat “symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery.”

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