BEUDAMED
    FDA Recall 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 · Initiated August 22, 2019

    Recall

    Recall Number
    Z-0221-2020
    Event Number
    83895
    Firm
    Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland
    FEI Number
    3003306248
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 22, 2019
    Posted
    October 30, 2019
    Terminated
    April 26, 2024

    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).

    Action

    A recall letter dated August 22, 2019 was issued on Abbott letterhead and was delivered by field representative visits beginning August 22, 2019 for the U.S. consignees. Foreign consignees were notified with a letter dated August 22, 2019 containing the same content but OUS model numbers and OUS contact information. Depending on the requirements by the local regulator, the letters may have been delivered by a field representative or via certified mail. The letter identified the affected product, problem and actions to be taken.

    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)