BEUDAMED
    FDA Recall Terminated

    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.

    Recall: Z-2264-2015 · Initiated July 15, 2015

    Recall

    Recall Number
    Z-2264-2015
    Event Number
    71719
    Firm
    Medtronic Cardiovascular Surgery-the Heart Valve Division
    FEI Number
    2025587
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 15, 2015
    Posted
    August 5, 2015
    Terminated
    May 20, 2016
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720

    Description

    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.

    Reason

    Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.

    Action

    An Urgent Medical Device Recall Letter dated July 2015 will be be sent to customers who purchased the EnVeo R Loading System because Medtronic has received 8 reports related to this issue out of 7347 potentially affected units. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer confirmation certificate and to email [email protected] or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.

    Distribution

    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    6,912 units total (540 units in US)