Use caution Medical device recall · FDA · Published June 29, 2026

Contego Neuroguard IEP 3-in-1 Stent System May Fail to Protect During Procedure

Recalled Neuroguard IEP 3-in-1 carotid stent systems with integrated filter may fail to open during procedures, risking loss of embolic protection. Affected units have specific reference numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2911-2026Medical device Contego Medical ›

Use caution until it’s fixed

Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.

✎ GovInfoNow plain-language explainer

Contego Medical is recalling certain Neuroguard IEP 3-in-1 carotid stent systems because a wire-to-filter bond issue could cause the integrated filter to fail during procedures. This might lead to loss of embolic protection, which is critical for preventing complications during vascular surgery. Read more at govinfonow.com/recall/314301-contego-neuroguard-iep-3-in-1-stent-system-may-fail.

Source Summary by GovInfoNow · govinfonow.com/recall/314301-contego-neuroguard-iep-3-in-1-stent-system-may-fail · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2911-2026

Cite this page

“Contego Neuroguard IEP 3-in-1 Stent System May Fail to Protect During Procedure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314301-contego-neuroguard-iep-3-in-1-stent-system-may-fail. Based on FDA recall #Z-2911-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2911-2026%22&limit=1).

The FDA announced on June 29, 2026, that Contego Medical, Inc. is recalling the Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection due to a potential failure of the integrated filter to open. This defect may result in the loss of intended embolic protection during procedures.

How to tell if you have it

Brand: Contego Medical
Product: Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
REF codes: 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
Lot codes: Z2460578D, Z2460740B, Z2460872C, Z2460909F, Z2460948D, Z2460957Q, Z2460578E, Z2460647S, Z2460706A, Z2460746C, Z2460774A, Z2460865C, Z2460872B, Z2460901B, Z2460909D, Z2460909K, Z2460945H, Z2460948I, Z2460963N, Z2460578F, Z2460662A, Z2460740A, Z2460774F, Z2460850A, Z2460900B, Z2460945F, Z2460957R, Z2460578G, Z2460635C, Z2460656A, Z2460707D, Z2460733A, Z2460766A, Z2460774B, Z2460780A, Z2460865A, Z2460871A, Z2460872D, Z2460900D, Z2460909B, Z2460909I, Z2460948F, Z2460963T, Z2460776A, Z2460893A, Z2460909G, Z2460948E, Z2460776B, Z2460865D, Z2460865E, Z2460901C, Z2460909E, Z2460909J, Z2460957P, Z2460963K, Z2460963P, Z2460776C, Z2460789H, Z2460850B, Z2460900C, Z2460916A, Z2460948H, Z2460998A, Z2460776D, Z2460878A, Z2460872A, Z2460872E, Z2460901A, Z2460909C, Z2460909H, Z2460945G, Z2460948G, Z2460966B, Z2460963J
Units affected: 5069

The hazard

According to the FDA, the device's integrated filter may fail to open following sheath retraction due to a wire-to-filter-bond issue. If this condition occurs during a procedure, it may result in the loss of intended integrated embolic protection.

Context

GovInfoNow's records show that Contego Medical has been involved in other recent recalls of similar products, including the CGuard Prime Carotid Stent System Recall on May 1, 2026, and Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus and System recalls on July 9, 2026. Other recent recalls of similar products include CGuard Prime Carotid Stent System Recall (2026-05-01) and Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus (2026-07-09).

How to tell if you have this one

Check the reference numbers listed in the recall: 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. The device includes specific lot numbers and unique identifiers.

Brand
Contego Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Reference
Look for the reference numbers on the device packaging or label: 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.
Contact Manufacturer
Reach out to Contego Medical directly for further assistance or to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

FDA distribution: “US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Delaware, Florida, Illinois, Indiana, Kentucky, Michigan, New Jersey, North Carolina, Pennsylvania, Virginia, Wisconsin.

Recall timeline

FDA published this recall 44 days after the firm started it.

Jun 29, 2026Firm started the recall
Aug 6, 2026FDA classified it Class II
Aug 12, 2026Published in FDA’s Enforcement Report
Aug 18, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/314301-contego-neuroguard-iep-3-in-1-stent-system-may-fail">Contego Neuroguard IEP 3-in-1 Stent System May Fail to Protect During Procedure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2911-2026 (June 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2911-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.