Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific identified a manufacturing defect in certain Direxion Torqueable Microcatheters where the hydrophilic coating on the outer surface was not fully cured during production, and nitinol sleeves had raised ridges from laser cutting misalignment. These defects could affect the device's performance during use.
- If you have one of the affected batch numbers (38240235, 38273744, 39092271, 40464692, 40464699, 40531397), stop using it and contact Boston Scientific immediately.
- Do not use any units from the affected material number M001195910.
- Report any problems or adverse events 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-0262-2027More 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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