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Open, Classified

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

FDA Recall Z-2911-2026 · Posted 2026-08-06

Recalling FirmContego Medical, Inc
Recall StatusOpen, Classified
Product CodeNIM
Date Initiated2026-06-29
Product Quantity5069

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.

Firm 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 [email protected] Questions can be directed to the firm at [email protected] and 919-459-7250 Extension 4.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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