Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP
Summary
The FDA issued a Class II for Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integr by Contego Medical LLC. 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 o.
Details
Source
Device Recall
External ID
Z-0131-2026
Action Date
2025-10-22
Status
Ongoing
Category
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
Lot/Code Info: 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)
Quantity Affected: 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-04
Company
Raleigh, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Contego Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Contego Medical LLC have FDA actions?
This is the only FDA action we have on record for Contego Medical LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0131-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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