CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Neuroguard IEP 1 Carotid Stent recalled by Contego Medical

Contego Medical is recalling Neuroguard IEP 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic, distributed nationwide in the US. The recall was initiated on 4 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/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 recalled568

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0131-2026
FDA event ID: 97522
Recalling firm: Contego Medical, Raleigh, NC
Classification: Class II
Status: Ongoing
Recall initiated: 4 Sep 2025
FDA classified: 10 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

4 Sep 2025	Recall initiated by company
10 Oct 2025	Classified by FDA	+36 days
22 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama California Colorado Connecticut Delaware Florida Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Contego Medical

All 2

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Neuroguard IEP 1 Carotid Stent recalled by Contego Medical	Contego Medical	Device Malfunction	Nationwide

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