FDA-Device2026-10-22Class IIPROCESSING DEFECT
Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific identified a defect in certain Direxion Torqueable Microcatheters where the hydrophilic coating on the tip was not fully cured during manufacturing, and nitinol sleeves have raised ridges from laser cutting misalignment. These defects could affect the device's performance during use.
- If you have received or used one of the affected batch numbers, contact Boston Scientific immediately.
- Do not use devices from the affected batches listed in this recall.
- Consult your healthcare provider about the status of your device and next steps.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.
Affected count
632
Manufactured in
Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork, Ireland
Products
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130;
Material Number: M001195320
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2027More 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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