BEUDAMED
    FDA Recall Terminated

    FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.

    Recall: Z-2126-2014 · Initiated July 11, 2014

    Recall

    Recall Number
    Z-2126-2014
    Event Number
    68789
    Firm
    Baxter Healthcare Corporation
    FEI Number
    3000121413
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 11, 2014
    Posted
    July 29, 2014
    Terminated
    May 27, 2015
    Address
    1 Baxter Way, Westlake Village, CA, 91362-3889

    Description

    FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.

    Reason

    Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.

    Action

    Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) sent an Urgent Medical Device Recall letter on July 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the recall is being conducted as a precautionary measure due to the possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored. The recall letter informs the customers of the safety risk and and actions to be taken. Customers with questions about the recall are instructed to contact the Synovis MCA Customer Service unit at (800) 510-3318 or (205) 941-0111.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.

    Quantity

    1,315 units