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balt usa, llc

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BALT USA, LLC — Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.