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Neuroguard IEP Carotid Stent System
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MEDICAL DEVICE RECALLMODERATE

Neuroguard IEP Carotid Stent System

Contego Medical recalls Neuroguard IEP carotid stent system over filter opening failure risk.

What to do

Do not use the affected Neuroguard IEP System. Return the product to Contego Medical for replacement or credit. Contact Contego Medical at 1-800-555-0199 for instructions.

Recalled
Listed
Updated
Recall No.
Z-2911-2026
Agency
FDA
Firm
Contego Medical, Inc
Recall ID
99353
Status
ONGOING

Why it was recalled

Contego Medical is recalling the Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection due to a wire-to-filter-bond issue that may prevent the integrated filter from opening after sheath retraction, potentially leading to loss of embolic protection during a procedure.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
NG-0630-140-2, Z2460578D, Z2460740B, Z2460872C, Z2460909F, Z2460948D, Z2460957Q
UDI-DI
00851616007583, 00851616007590, 00851616007606, 00851616007613, 00851616007644, 00851616007651, 00851616007637, 00851616007620

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification