Boston Scientific ENROUTE Transcarotid Neuroprotection System — Class I medical device recall Z-2977-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-08-26, distributed nationwide. Potential for arterial sheath tip separation or partial tip separation during use.
| Recall number | Z-2977-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2026-07-09 |
| Classified | 2026-08-20 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, JM |
| Quantity | 115,458 units |
| UPC / GTIN / UDI-DI | 00811311020829 |
| Lot numbers | 200832, 200850, 201057, 201070, 201087, 201113, 201128, 201143, 201157, 201177, 201190, 201220, 201235, 201312, 201333, 201351, 201379, 201407, 201422, 201487, 300015, 300028, 300043, 300058, 300075, 300099, 300114, 300135, 300143, 300154, 300168, 300188, 300203, 300213, 300229, 300252, 300262, 300271, 300311, 300325 and 287 more |
Product
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Reason for recall
Potential for arterial sheath tip separation or partial tip separation during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2977-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.