Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific has recalled specific batches of its Direxion Torqueable Microcatheter due to manufacturing defects. The microcatheters have insufficient UV curing of the hydrophilic coating on the outer surface and raised ridges on nitinol sleeves from laser cutting misalignment. These defects could affect device performance during medical procedures.
- If you have received or implanted one of the affected batches (see batch numbers in full recall notice), contact Boston Scientific or your healthcare provider immediately.
- Do not use affected units; quarantine and return them to the manufacturer.
- Report any adverse events or complications 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-0240-2027More 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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