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U.S. Department of Health and Human Services

Class 2 Device Recall Neuroguard IEP 3 in 1 Carotid Stent and PostDilation Balloon System with Integrated Embolic Protection

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 Class 2 Device Recall Neuroguard IEP 3 in 1 Carotid Stent and PostDilation Balloon System with Integrated Embolic Protectionsee related information
Date Initiated by FirmSeptember 04, 2025
Date PostedOctober 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0131-2026
Recall Event ID 97522
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-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
Code Information 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)
FEI Number 3011471056
Recalling Firm/
Manufacturer		 Contego Medical LLC
3801 Lake Boone Trl Ste 100
Raleigh NC 27607-2994
For Additional Information Contact
888-708-7271
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn 9/4/2025, communication and training to the field representatives started with in person letter distribution following immediately after. Customers were asked to do the following: Action Required 1) Inventory Check: Medtronic and Contego sales representatives will visit your facility to conduct an inventory count of devices from the affected lots. 2) Quarantine Affected Devices: Any identified devices will be removed from use and quarantined by the Medtronic or Contego team. 3) Return: Medtronic and Contego will remove affected devices. If replacements are desired, they can be provided during the same visit. 4) Confirmation: Sign and return the enclosed acknowledgment form to confirm receipt of this advisory and the completion of actions performed by Medtronic or Contego. 5) Please email the completed form to Contego Medical recall@contegomedical.com as soon as possible and retain a copy of the form to provide to the representative at the time of their visit. If you have questions, contact the firm's Recall Support Team at recall@contegomedical.com or call 919-459-7250 Extension 4.
Quantity in Commerce568
DistributionUS Nationwide distribution in the states of FL, CO, CA, IL, NC, KY, TX, PA, DE, NJ, IN, NY, OH, LA, OK, SC, CT, WI, MA, KS, UT, MD, AL.
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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