TemporaryFDAOngoing
Can cause harm that is usually temporary.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Check the device or its packaging for
Material Number: M001195750; UDI-DI: 08714729839729; Batch Numbers: 38049562, 38112644, 38112645, 38181975, 38259489, 38273638, 38342770, 38346223, 38399380, 38707974, 39074174, 39074176, 39092273, 40470667, 40476303, 40485786, 40485787, 40493318, 40495100, 40507439, 40512986, 40512987, 40523966, 40524003, 40531398, 40531399;
- Why
- 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.
- Distributed
- 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.
- Company
- Boston Scientific Cork, Ltd.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0258-2027 · retrieved 22 October 2026
Read the official notice