Boston Scientific Cork, Ltd. — Medical Devices Recall

Product Description: Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840

Reason for Recall: 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.

Distribution Pattern: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa