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's tip may not have been properly cured, and nitinol sleeves may have raised ridges from laser cutting misalignment. These defects could affect device performance.
- Check if you have a Direxion Torqueable Microcatheter with material number M001195480 and one of the affected batch numbers: 38649876, 38668791, 39074172, 39074173, 40482627, or 40482628.
- If you have an affected device, contact Boston Scientific or your healthcare provider immediately for guidance.
- Do not use the device if it is part of the recall.
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-0246-2027More 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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