Recall Z-0131-2026— Contego Medical LLC
Class II · Ongoing
Class II FDA medical device recall by Contego Medical LLC, initiated 2025-09-04. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Contego Medical LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-04
- Firm location
- Raleigh, NC, United States
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.