Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Boston Scientific Cork, Ltd. has initiated a Class II recall for specific Direxion Torqueable Microcatheters (Material Number M001195280) due to insufficient UV curing of the distal segment's hydrophilic coating and raised ridges on nitinol sleeves caused by laser cutting misalignment.
Boston Scientific Cork, Ltd., manufacturing engineers, quality control inspectors, and clinicians utilizing the Direxion Torqueable Microcatheter in vascular procedures.
This recall identifies two distinct mechanical failures: a chemical processing error (insufficient curing) and a precision machining error (laser misalignment). These issues potentially compromise the device's lubricity and structural integrity, which may lead to clinical complications during navigation or vessel trauma. The 'Ongoing' status suggests that reconciliation of affected units is still in progress.
Quality teams should review UV curing validation records and laser cutting calibration logs for catheter production lines. Manufacturing engineering should investigate the root cause of nitinol sleeve ridges and coating adhesion failures to ensure these defects are captured during in-process inspections.
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/SINGLE/021/J/1RO/155; Material Number: M001195280. Firm: Boston Scientific Cork, Ltd. (Cork Ireland). Status: Ongoing.
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