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 tip of the catheters may not have been properly cured, and some nitinol sleeves have raised ridges from laser cutting misalignment. These defects could affect the device's performance during medical procedures.
- Check your medical records or device documentation to determine if you received one of the affected batches (batch numbers 37942457–40525677).
- Contact your healthcare provider immediately if you have one of these devices or recently had a procedure using this catheter.
- Do not use any affected devices; return them to the manufacturer or your hospital pharmacy.
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-0223-2027More 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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