Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System… — Class II medical device recall Z-2911-2026
Ongoing recall by Contego Medical, Inc, reported 2026-08-12, distributed nationwide. Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated fil
| Recall number | Z-2911-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Contego Medical, Inc, Raleigh, NC, United States |
| Recall initiated | 2026-06-29 |
| Classified | 2026-08-06 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 5,069 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00851616007583, 00851616007590, 00851616007606, 00851616007613, 00851616007620, 00851616007637, 00851616007644, 00851616007651 |
| Lot numbers | Z2460635C, Z2460647S, Z2460656A, Z2460662A, Z2460706A, Z2460707D, Z2460733A, Z2460740A, Z2460740B, Z2460746C, Z2460766A, Z2460774A, Z2460774B, Z2460774F, Z2460780A, Z2460789H, Z2460850A, Z2460850B, Z2460865A, Z2460865C, Z2460865D, Z2460865E, Z2460871A, Z2460872A, Z2460872B, Z2460872C, Z2460872D, Z2460872E, Z2460878A, Z2460893A, Z2460900B, Z2460900C, Z2460900D, Z2460901A, Z2460901B, Z2460901C, Z2460909B, Z2460909C, Z2460909D, Z2460909E and 26 more |
| Model numbers | NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, 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-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Reason for recall
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
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-2911-2026. 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.