Boston Scientific Direxion Torqueable Microcatheter recalled for coating defect and manufacturing misalignment
What this means
Boston Scientific has recalled certain Direxion Torqueable Microcatheters due to manufacturing defects. The hydrophilic coating on the catheter tip may not have been properly cured, and raised ridges on the nitinol sleeves resulted from laser cutting misalignment. These defects could affect the device's performance during medical procedures.
- If you have one of the affected batch numbers, contact your healthcare provider or Boston Scientific immediately
- Do not use the device if your batch number matches the recall list
- Check the material number (M001195230) and batch number on your device packaging
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-0226-2027More 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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