Recall Z-2911-2026 ยท NIM Stent, Carotid
Contego Medical, Inc
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
| Date | Aug 6, 2026 (initiated Jun 29, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 6/29/2026, recall notices started being delivered to healthcare professionals and risk managers by Medtronic sales representatives who informed of the following: 1) Sales representatives will visit, conduct inventory counts, quarantine, and remove unused affected devices. 2) If replacements are desired, they can be provided. 3) Complete and return the acknowledgment form via email to recall@contegomedical.com Questions can be directed to the firm at recall@contegomedical.com and 919-459-7250 Extension 4. |
| Quantity | 5069 |
| Distribution | US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.