Boston Scientific Direxion Torqueable Microcatheter recalled for defective coating and manufacturing defects
What this means
Boston Scientific has recalled certain Direxion Torqueable Microcatheters due to manufacturing defects. The hydrophilic coating on the outer surface of the catheter tip may not be fully cured, and nitinol sleeves may have raised edges from laser cutting misalignment. These defects could affect the catheter's performance during use.
- Contact your healthcare provider or hospital if you have received this device
- Do not use affected batches (numbers 38049562–40531399 listed in the FDA notice)
- Check the material number M001195750 and batch number on your device packaging
- Report any issues to Boston Scientific or the FDA
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-0258-2027More 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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