Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific identified a defect in certain Direxion Torqueable Microcatheters where the hydrophilic coating on the outer surface was not fully cured during manufacturing. Additionally, some units have raised ridges on nitinol sleeves caused by laser cutting misalignment. These defects could affect device performance during medical procedures.
- If you have one of the affected batch numbers, contact Boston Scientific immediately
- Do not use the device if it is from one of the recalled batches
- Consult with your healthcare provider about replacement options
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-0251-2027More 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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