BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0131-2026 · Initiated September 4, 2025

    Recall

    Recall Number
    Z-0131-2026
    Event Number
    97522
    Firm
    Contego Medical LLC
    FEI Number
    3011471056
    Product Code
    NIM
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 4, 2025
    Posted
    October 10, 2025
    Address
    3801 Lake Boone Trl, Ste 100, Raleigh, NC, 27607-2994

    Description

    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

    Reason

    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.

    Action

    On 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 [email protected] 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 [email protected] or call 919-459-7250 Extension 4.

    Distribution

    US 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.

    Quantity

    568