BEUDAMED
    FDA Recall Terminated

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    Recall: Z-1384-2018 · Initiated February 21, 2018

    Recall

    Recall Number
    Z-1384-2018
    Event Number
    79646
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 21, 2018
    Posted
    April 16, 2018
    Terminated
    March 18, 2020
    Address
    15 Law Dr, Fairfield, NJ, 07004-3206

    Description

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    Reason

    The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

    Action

    Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.

    Distribution

    US Nationwide Distribution

    Quantity

    655