Recall Z-2977-2026 ยท NTE Temporary Carotid Catheter For Embolic Capture
Boston Scientific Corporation
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
| Date | Aug 20, 2026 (initiated Jul 9, 2026) |
| Status | Open, Classified |
| Reason | Potential for arterial sheath tip separation or partial tip separation during use. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued an "Urgent Medical Device Removal" notice to its consignees on 7/9/2026 via FedEx. The notice explained the issue, potential risk, and requested the following actions to be taken: 1. Immediately discontinue use and segregate Affected Product. 2. Complete and return the Reply Verification Tracking Form (RVTF) to get a Return Goods Authorization (RGA) number. " Indicate the quantity of SINGLE units you will be returning for credit " If you have product that is listed and not included on your RVTF, provide the material number, lot number, and quantity you intend to |
| Quantity | 115,458 units |
| Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153485 | ENROUTE Transcarotid Neuroprotection System Silk Road Medical, Inc., Mar 10, 2016 |