Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific Cork, Ltd. is recalling certain Direxion Torqueable Microcatheters due to manufacturing defects: the hydrophilic coating on the distal segment was not properly cured by ultraviolet light, and nitinol sleeves have raised ridges from laser cutting misalignment. These defects may affect device performance during medical procedures.
- Check if you have one of the affected batch numbers (37914480–40513103).
- Contact your supplier or Boston Scientific immediately if you have stock of this product.
- Do not use affected units; follow your facility's quarantine and return procedures.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2027More Boston Scientific recalls
- FDA-Device2026-10-22Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
- FDA-Device2026-10-22Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
- FDA-Device2026-10-22Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
- FDA-Device2026-10-22Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
- FDA-Device2026-10-22Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
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