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Device recall: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; (Boston Scientific Cork, Ltd.)
Open, Classified. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Read the full story at U.S. FDA device recalls via openFDA (opens in a new tab)
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Headline and summary from U.S. FDA device recalls via openFDA; the full story is on the publisher's site. Nothing here is investment advice.