BEUDAMED
    FDA Enforcement Class I Terminated

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    Recall: Z-0221-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0221-2020
    Event ID
    83895
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thoratec Switzerland GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 6, 2019
    Initiation Date
    August 22, 2019
    Classification Date
    October 30, 2019
    Termination Date
    April 26, 2024
    Address
    Technoparkstrasse 1, Zurich, N/A, Switzerland

    Description

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    Reason

    Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

    Code Info

    U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024

    Distribution

    Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

    Quantity

    664 units (381 U.S. and 283 OUS)