Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific Cork, Ltd. has recalled specific batches of the Direxion Torqueable Microcatheter due to manufacturing defects: the hydrophilic coating on the distal segment was not fully cured during UV treatment, and raised ridges on nitinol sleeves resulted from laser cutting misalignment. These defects could affect device performance during medical procedures.
- If you have one of the affected batch numbers (38149822, 38210076, 38415917, 38595649, 38708406, 39141265), do not use the device.
- Contact Boston Scientific or your distributor immediately for instructions on device return or replacement.
- Notify your healthcare provider if you have questions about affected devices.
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-0242-2027More 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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