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 distal segment and misaligned laser cuts on nitinol sleeves. These defects could affect the device's performance during medical procedures.
- Check your device batch number against the FDA recall list
- Contact Boston Scientific or your healthcare provider if you have an affected device
- Do not use the device if it is in a recalled batch
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
2547
Manufactured in
Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork, Ireland
Products
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130;
Material Number: M001195210
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2027More 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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