Recall Z-0233-2027 ยท KRA Catheter, Continuous Flush
Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300
| Date | Oct 22, 2026 (initiated Sep 16, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On September 16, 2026, Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: 1. Immediately stop further use or distribution and segregate affected product (see Attachment 1 for identification of the affected devices). 2. Forward this notice to relevant personnel and any facilities to which the product was transferred. 3. Continue to follow the standard of practice when monitoring patients treated with the product. 4. Complete and return the enclosed Reply Verification Tracking Form per the included instructions. 5. Return product to |
| Quantity | 3284 |
| 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, Jap |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters Boston Scientific Corporation, May 16, 2017 |