Boston Scientific Cork, Ltd.: Catheter, Continuous Flush
Boston Scientific is recalling Direxion Torqueable Microcatheters worldwide due to manufacturing defects in the hydrophilic coating and nitinol sleeve that could affect device performance. The coating may not have been properly cured, and the sleeve may have raised ridges from laser cutting errors. This Class II recall affects catheters distributed across the US, Puerto Rico, and numerous countries internationally.
- Recalling firm
- Boston Scientific Cork, Ltd.
- Product
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5c2469f7-7b9f-445f-bf32-86d3aead0d63