Contego Medical LLC: Device Recall
Recall #Z-0131-2026 · 09/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0131-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Contego Medical LLC
- Status
- Ongoing
- Date Initiated
- 09/04/2025
- Location
- Raleigh, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 568
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.
Product Description
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
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.