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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 29, 2026
Date PostedAugust 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2911-2026
Recall Event ID 99353
PMA NumberP240009 
Product Classification Stent, carotid - Product Code NIM
ProductNeuroguard 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
Code Information REF/UDI-DI/Lot: NG-0630-140-2/00851616007583/Z2460578D,Z2460740B, Z2460872C, Z2460909F, Z2460948D, Z2460957Q; NG-0640-140-2/00851616007590/Z2460578E, Z2460647S, Z2460706A, Z2460746C, Z2460774A, Z2460865C, Z2460872B, Z2460901B, Z2460909D, Z2460909K, Z2460945H, Z2460948I, Z2460963N; NG-0730-140-2/00851616007606/Z2460578F, Z2460662A, Z2460740A , Z2460774F, Z2460850A, Z2460900B, Z2460945F, Z2460957R; NG-0740-140-2/00851616007613/Z2460578G, Z2460635C, Z2460656A, Z2460707D, Z2460733A, Z2460766A, Z2460774B, Z2460780A , Z2460865A, Z2460871A, Z2460872D, Z2460900D, Z2460909B, Z2460909I, Z2460948F, Z2460963T; NG-NV-6-30/00851616007644/Z2460776A, Z2460893A, Z2460909G, Z2460948E; NG-NV-6-40/00851616007651/Z2460776B, Z2460865D, Z2460865E, Z2460901C, Z2460909E, Z2460909J, Z2460957P, Z2460963K, Z2460963P; NG-NV-7-30/00851616007637/Z2460776C, Z2460789H, Z2460850B, Z2460900C, Z2460916A, Z2460948H, Z2460998A; NG-NV-7-40/00851616007620/Z2460776D, Z2460878A, Z2460872A, Z2460872E, Z2460901A, Z2460909C, Z2460909H, Z2460945G, Z2460948G, Z2460966B, Z2460963J;
FEI Number 3011471056
Recalling Firm/
Manufacturer		 Contego Medical, Inc
3801 Lake Boone Trl Ste 100
Raleigh NC 27607-2994
For Additional Information Contact
919-459-7250
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionOn 6/29/2026, recall notices started being delivered to healthcare professionals and risk managers by Medtronic sales representatives who informed of the following: 1) Sales representatives will visit, conduct inventory counts, quarantine, and remove unused affected devices. 2) If replacements are desired, they can be provided. 3) Complete and return the acknowledgment form via email to recall@contegomedical.com Questions can be directed to the firm at recall@contegomedical.com and 919-459-7250 Extension 4.
Quantity in Commerce5069
DistributionUS Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NIM
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