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Product tested positive Salmonella .
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.