Medical Device Recall: 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
Contego Medical LLC · September 4, 2025
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.
Distribution
US Nationwide distribution in the states of FL, CO, CA, IL, NC, KY, TX, PA, DE, NJ, IN, NY, OH, LA, OK, SC, CT, WI, MA, KS, UT, MD, AL.
States Affected
NATIONWIDE
Quantity Affected
568
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0131-2026
Status: ongoing
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