Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific has recalled specific batches of Direxion Torqueable Microcatheters due to manufacturing defects. The hydrophilic coating on the outer surface was not cured properly, and nitinol sleeves have raised ridges from laser cutting misalignment. These defects could affect the device's performance during medical procedures.
- Check your device material number M001195470 and batch number against the list provided by Boston Scientific
- Contact Boston Scientific or your healthcare provider if you have one of the affected batches
- Do not use the device if it is identified as part of a recalled batch
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-0245-2027More 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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