Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific has recalled specific batches of the Direxion Torqueable Microcatheter due to manufacturing defects. The hydrophilic coating on the outer surface of the catheter tip was not properly cured, and nitinol sleeves have raised ridges from laser cutting misalignment. These defects may affect device performance during use.
- Check if you have a microcatheter from the affected batch numbers (37881102–39092696; see full list in FDA notice).
- Contact Boston Scientific or your healthcare provider with the batch number from your device packaging.
- Do not use the device if it is from an affected batch; return it to Boston Scientific or your hospital's device management team.
- Report any device-related problems to the FDA MedWatch program.
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-0238-2027More 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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