FDA recall, , Moderate risk
Contego Medical Neuroguard IEP Carotid Stent and Balloon System
The Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System may fail to open its integrated filter.
Summary by Recall Canary from the FDA notice
What happened
Contego Medical, Inc., of Raleigh, North Carolina, recalled the Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System) on June 29, 2026, because a wire-to-filter-bond issue may cause the integrated filter to fail to open following sheath retraction, potentially resulting in loss of intended integrated embolic protection during a procedure.
The FDA added the recall to its Enforcement Report on August 6, 2026. The system was distributed in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
- UDI-DI
- 00851616007583
- 00851616007590
- 00851616007606
- 00851616007613
- 00851616007644
- 00851616007651
- 00851616007637
- 00851616007620
- Lot code
- NG-0630-140-2
- Z2460578D
- Z2460740B
- Z2460872C
- Z2460909F
- Z2460948D
- Z2460957Q
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Illinois, Florida, North Carolina, Wisconsin, Kentucky, Alabama, Virginia, Delaware, New Jersey, Pennsylvania, Indiana, Michigan, California.
- Company
- Contego Medical, IncRaleigh, North Carolina
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99353
- Recall number
- Z-2911-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
