Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195
Boston Scientific Cork, Ltd. has initiated a Class II recall for the Direxion Torqueable Microcatheter due to insufficient UV curing of the distal segment's hydrophilic coating and laser cutting misalignment on nitinol sleeves.
This recall affects Boston Scientific Cork, Ltd., healthcare providers utilizing the Direxion Torqueable Microcatheter (Material Number M001195290), and quality/manufacturing departments responsible for coating and laser cutting processes.
Insufficient coating curing and mechanical defects (raised ridges) on a microcatheter distal segment may compromise device performance or patient safety during endovascular procedures. This suggests potential gaps in manufacturing process controls for UV curing and laser alignment verification.
Quality teams should review UV curing validation protocols for hydrophilic coatings and verify laser cutting alignment specifications for nitinol components. Affected inventory should be quarantined according to the manufacturer's specific material number (M001195290).
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/SWAN/1RO/105; Material Number: M001195290. Firm: Boston Scientific Cork, Ltd. (Cork Ireland). Status: Ongoing.
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