The Recall Desk
HighFDA (Devices)·Z-0131-2026·Announced 2025-10-22

[pending] Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protect

Pending LLM rewrite. Source: FDA_DEVICE Z-0131-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
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
Manufacturer
Contego Medical LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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)

Distribution

Distributed nationwide across the United States.

Related recalls

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