Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System… — Class II medical device recall Z-0131-2026
Ongoing recall by Contego Medical LLC, reported 2025-10-22, distributed nationwide. Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated fil
| Recall number | Z-0131-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Contego Medical LLC, Raleigh, NC, United States |
| Recall initiated | 2025-09-04 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 568 |
| UPC / GTIN / UDI-DI | 00851616007590, 00851616007613, 00851616007620, 00851616007651 |
| Model numbers | NG-0640-140-2, NG-0740-140-2, NG-NV-6-40, NG-NV-7-40 |
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
Reason for recall
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.
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-0131-2026. 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.