Boston Scientific Cork, Ltd.: Catheter, Continuous Flush
Recall Summary Boston Scientific is recalling Direxion Torqueable Microcatheters used in medical procedures due to manufacturing defects in the hydrophilic coating and laser-cut components that may not function as intended. The affected catheters were distributed worldwide, including throughout the United States and Puerto Rico. This is a Class II recall, meaning the product could cause serious health problems or temporary adverse health consequences.
- Recalling firm
- Boston Scientific Cork, Ltd.
- Product
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270
- 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/4dbc5219-2717-4206-9a2e-7b09295dc781