Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195
Boston Scientific Cork, Ltd. is recalling the Direxion Torqueable Microcatheter due to insufficient UV curing of the distal segment's hydrophilic coating and raised ridges on nitinol sleeves caused by laser cutting misalignment.
This recall affects Boston Scientific Cork, Ltd., healthcare providers using the Direxion Torqueable Microcatheter (Material Number: M001195750), and quality/manufacturing personnel responsible for catheter coating and nitinol processing.
This Class II recall indicates a manufacturing failure involving both chemical processing (UV curing) and mechanical precision (laser cutting). The presence of raised ridges and improperly cured coatings on a torqueable microcatheter distal segment may pose risks during navigation or delivery, potentially impacting the safety profile of the device. The ongoing status suggests that mitigation and accounting for affected units are still in progress.
Quality teams should review UV curing validation protocols for hydrophilic coatings and inspect laser-cutting calibration schedules for nitinol components. Regulatory and clinical teams should monitor for adverse events related to coating integrity or catheter surface irregularities.
Class II. Reason: 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.. Product: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750. Firm: Boston Scientific Cork, Ltd. (Cork Ireland). Status: Ongoing.
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