BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.

    Recall: Z-1449-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1449-2020
    Event ID
    84837
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic CoreValve LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 18, 2020
    Initiation Date
    January 14, 2020
    Classification Date
    March 6, 2020
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720, United States

    Description

    Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: 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.

    Code Info

    GTIN: 00643169707535

    Distribution

    US Nationwide distribution in the states of Ohio and Kansas.

    Quantity

    6