BEUDAMED
    FDA Recall Terminated

    ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

    Recall: Z-0090-2021 · Initiated May 22, 2020

    Recall

    Recall Number
    Z-0090-2021
    Event Number
    85807
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    3023245
    Product Code
    OBJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 22, 2020
    Terminated
    October 15, 2021
    Address
    22010 SE 51st St, Issaquah, WA, 98029-7298

    Description

    ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

    Reason

    Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

    Action

    On 05/22/2020, the firm notified customers via telephone of the recall and send on 05/26/2020 an email with an attached "URGENT SAFETY ADVISORY NOTIFICATION" Letter inform customer that the Recalling Firm has received reports of left atrial perforations and Atrioventricular Node block occurring while using the affected product. The customer notification instructs customers to: -Immediately stop performing procedures using the affected catheters and segregate the product. -All remaining affected inventory in their possession will be collected. The following steps outline the sequence of this process: -Users of the device have been contacted personally by the Recalling Firm's Ultrasound Management; -Customers will be reimbursed for their remaining, unused inventory; -A Clinical Specialist will call to schedule a time to document and retrieve inventory. OR Customers may ship the remaining inventory to the following address. Customers that wish to ship remaining inventory, should inform the Clinical Specialist of this when they are contacted. Address to return products: Siemens Healthineers Ultrasound Attention: Kristen Clyman 22010 S.E. 51st Street Issaquah, WA 98029 Customer are also instructed to: -Complete the Recall Acknowledgement Form and return to the Recalling Firm as soon as possible and email to [email protected], and -Ensure that all users of the affected products within your organization and others who may need to be informed receive the safety relevant information provided with the notice and take the actions specified therein.

    Distribution

    U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada