Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195
Boston Scientific Cork, Ltd. has initiated a Class II recall for specific Direxion Torqueable Microcatheters (Material Number M001195440) due to insufficient UV curing of the distal hydrophilic coating and raised ridges on nitinol sleeves caused by laser cutting misalignment.
This recall affects Boston Scientific Cork, Ltd. and clinical users of the Direxion Torqueable Microcatheter, specifically impacting manufacturing, quality control, and interventional radiology departments.
The presence of raised ridges on nitinol sleeves and inadequately cured coatings suggests potential failures in manufacturing process controls and validated state maintenance. Such defects could theoretically pose risks during endovascular procedures, such as vessel trauma or embolic potential from coating fragments, though the source does not explicitly state clinical outcomes.
QA and manufacturing teams should review UV curing validation protocols for hydrophilic coatings and verify laser cutting alignment parameters for nitinol components. Regulatory teams should monitor the ongoing status of this recall to determine if additional material numbers or geographic regions are impacted.
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/027/BERN/1RO/130; Material Number: M001195440. Firm: Boston Scientific Cork, Ltd. (Cork Ireland). Status: Ongoing.
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