FDA-Device2026-10-22Class IIPROCESSING DEFECT
Boston Scientific Direxion Torqueable Microcatheter recalled for coating defect and manufacturing misalignment
What this means
Boston Scientific has recalled certain Direxion Torqueable Microcatheters due to manufacturing defects: the hydrophilic coating on the catheter's tip may not be fully cured, and nitinol sleeves may have raised ridges from laser cutting misalignment. These defects could affect device performance during use.
- If you have received or implanted one of the affected batch numbers listed (38181961 through 40502039), contact Boston Scientific immediately
- Do not use affected units; quarantine them and return to the distributor or manufacturer
- Consult with your healthcare provider if you have questions about your procedure or device
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
620
Manufactured in
Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork, Ireland
Products
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130;
Material Number: M001195440
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2027More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.