FDA-Device2026-10-22Class IIPROCESSING DEFECT
Boston Scientific Direxion Torqueable Microcatheter recalled for coating and manufacturing defects
What this means
Boston Scientific has recalled certain Direxion Torqueable Microcatheters due to manufacturing defects in the hydrophilic coating on the outer surface and raised ridges on nitinol sleeves caused by laser cutting misalignment. These defects could affect the device's performance during medical procedures.
- If you have one of the affected batch numbers (37981345–40512995), contact your healthcare provider or Boston Scientific immediately.
- Do not use the device if you have confirmed it matches an affected batch number.
- Healthcare facilities should check their inventory against the batch numbers listed in the FDA notice.
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
459
Manufactured in
Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork, Ireland
Products
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155;
Material Number: M001195220
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0225-2027More 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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