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Recalls → Z-0229-2027
Class II Recall · Z-0229-2027 Report Date: 2026-10-28 · Status: Ongoing

Boston Scientific Cork, Ltd. — Medical Devices Recall

Product Description: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
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
View Linked Facility Profile (FEI FEI-3895D13A) → Verify on openFDA ↗