Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific identified a manufacturing defect in specific batches of the Direxion Torqueable Microcatheter. The hydrophilic coating on the tip of the catheter was not properly cured, and metal sleeves have raised edges from laser cutting misalignment. These defects could affect device performance during medical procedures.
- If you received this device, contact Boston Scientific immediately with the batch number from your product.
- Do not use the affected microcatheters (batch numbers 38049561, 38065517, 38092409, 38745199, 38745480, 39092274, 40482626, 40482629, 40497899, 40497980, 40502330, 40504597, 40504598, 40531426).
- Return or quarantine affected units per Boston Scientific's instructions.
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-0241-2027More 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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