FDA Medical devices recall ·
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with… recall
- Recall number
- Z-0131-2026
- Date
- (initiated September 4, 2025)
- Company / brand
- Contego Medical, Inc
3801 Lake Boone Trl Ste 100, Raleigh, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 568
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot(Expiration): NG-0740-140-2/00851616007613/Z2460707D(Z2460707D), Z2460733A(03/05/2027), Z2460766A(04/07/2027), Z2460774B(04/17/2027), Z2460780A(04/18/2027); NG-0640-140-2/00851616007590/Z2460746C(03/20/2027), Z2460774A(04/18/2027); NG-NV-7-40/00851616007620/Z2460776D(04/14/2027); NG-NV-6-40/00851616007651/Z2460776B(04/16/2027)
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: Alabama California Colorado Connecticut Delaware Florida Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas Utah Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0131-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.