Reported Oct 22, 2025 · Ongoing

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP…

Contego Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Contego Medical LLC · 3801 Lake Boone Trl Ste 100 · Raleigh, NC · 27607-2994

Is this the product you have?

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

Lot codes and dates: 4 of 4 products
Products covered by this recall
# Barcodes Product as published
1 00851616007613 NG-0740-140-2/00851616007613/Z2460707D(Z2460707D), Z2460733A(03/05/2027), Z2460766A(04/07/2027), Z2460774B(04/17/2027), Z2460780A(04/18/2027)
2 00851616007590 NG-0640-140-2/00851616007590/Z2460746C(03/20/2027), Z2460774A(04/18/2027)
3 00851616007620 NG-NV-7-40/00851616007620/Z2460776D(04/14/2027)
4 00851616007651 NG-NV-6-40/00851616007651/Z2460776B(04/16/2027)
Amount recalled: 568

Where it was sold

Nationwide
FL
CO
CA
IL
NC
KY
TX
PA
DE
NJ
IN
NY
OH
LA
OK
SC
CT
WI
MA
KS
UT
MD
AL

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`00851616007613`	NG-0740-140-2/00851616007613/Z2460707D(Z2460707D), Z2460733A(03/05/2027), Z2460766A(04/07/2027), Z2460774B(04/17/2027), Z2460780A(04/18/2027)
2	`00851616007590`	NG-0640-140-2/00851616007590/Z2460746C(03/20/2027), Z2460774A(04/18/2027)
3	`00851616007620`	NG-NV-7-40/00851616007620/Z2460776D(04/14/2027)
4	`00851616007651`	NG-NV-6-40/00851616007651/Z2460776B(04/16/2027)