BEUDAMED
    FDA Recall Open, Classified

    Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.

    Recall: Z-1450-2020 · Initiated January 14, 2020

    Recall

    Recall Number
    Z-1450-2020
    Event Number
    84837
    Firm
    Medtronic CoreValve LLC
    FEI Number
    2025587
    Product Code
    DTI
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 14, 2020
    Posted
    February 14, 2020
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720

    Description

    Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.

    Reason

    Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.

    Action

    The firm initiated the recall by email or verbal contact on 01/14/2020. The direct consignees (sales representatives) were directed to quarantine and return the affected product. On 02/05/2020, consignees (hospitals) were notified by letter delivered by the Medtronic Sales Representatives. The notices directed the consignee to not use the affected product for clinical use, quarantine and return affected product. Affected product will be replaced by Medtronic.

    Distribution

    US Nationwide distribution in the states of Ohio and Kansas.

    Quantity

    6