Boston Scientific Direxion Torqueable Microcatheter recalled for coating and sleeve defects
What this means
Boston Scientific has recalled certain Direxion Torqueable Microcatheters due to manufacturing defects. The hydrophilic coating on the tip may not have been properly cured, and the nitinol sleeves may have raised ridges from laser cutting misalignment. These defects could affect device performance during use.
- Check if you have one of the affected batch numbers: 38061601, 38063600, 38434622, 38434623, 38650006, 38650007, 40482630, 40482631, 40502273, or 40502274.
- Contact Boston Scientific or your supplier for instructions on return or replacement.
- Do not use affected units until you receive guidance from Boston Scientific.
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-0248-2027More 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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