Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific's Direxion Torqueable Microcatheter has a manufacturing defect affecting the hydrophilic coating on the distal tip and nitinol sleeve, caused by insufficient UV curing and laser cutting misalignment. The defect may compromise the device's performance during medical procedures. This is a Class II recall affecting approximately 3,284 units distributed worldwide.
- If you are a healthcare facility or provider, check your inventory against the affected batch numbers listed in the FDA notice.
- Do not use affected units; contact Boston Scientific for instructions on device return or replacement.
- 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-0233-2027More 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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