BEUDAMED
    FDA Recall Terminated

    MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA

    Recall: Z-1935-2016 · Initiated May 13, 2016

    Recall

    Recall Number
    Z-1935-2016
    Event Number
    74225
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    May 13, 2016
    Terminated
    March 22, 2019
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA

    Reason

    It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

    Action

    Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

    Worldwide Distribution.

    Quantity

    31,030 units (US); 15,604 units (OUS)