Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific is recalling certain Direxion Torqueable Microcatheters due to manufacturing defects: the hydrophilic coating on the catheter tip may not have been properly cured, and nitinol sleeves may have raised ridges from laser cutting misalignment. These defects could affect the catheter's performance during use.
- Check if you have a device with Material Number M001195290 and one of these batch numbers: 38362172, 38362173, 38530450, or 38595659.
- Contact Boston Scientific or your healthcare provider for instructions on device inspection or replacement.
- Do not use the device if you suspect it has the defect.
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-0232-2027More 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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