Device recall: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/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.

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