BEUDAMED
    FDA Recall Open, Classified

    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

    Recall: Z-0842-2024 · Initiated January 3, 2024

    Recall

    Recall Number
    Z-0842-2024
    Event Number
    93697
    Firm
    Thoratec Corp.
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 3, 2024
    Posted
    February 2, 2024
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

    Reason

    Due to software and controller systems that results in unexpected pump start or pump stop.

    Action

    On 01/03/2024, the firm sent an Urgent Medical Device Correction Letter via hand delivery to U.S. customers informing them that Abbott has received complaints for the HeartMate Touch Communication System application (App) version 1.0.32 due to unintentional start/stop of the HeartMate 3 Left Ventricle Assist Device (LVAD). -Customer should be able to identify the software version of the HeartMate Touch App by tapping "Menu" and "About" on the left-hand panel on the HeartMate Touch screen. -When the "STOP PUMP" sequence needs to be performed, follow the instructions in the Instructions For Use (IFU), Chapter 4 HeartMate Touch Communication System Pages 4-58 to 4-59. -The user can prevent the unintentional LVAD start/stop from occurring by following the IFU and these additional guidance and recommendations. Note that communication may also be interrupted if the Wireless Adaptor is disconnected from the HeartMate Touch system prior to completion of the STOP PUMP sequence. -Do not disconnect the HeartMate System Controller white cable or the Wireless Adapter from the Power Module until STOP PUMP sequence screen with the red progress bar is no longer visible and the STOP PUMP screen changes automatically. -During pump priming, do not disconnect the pump until the timer reaches zero, the pump stops, and the Priming is complete message appears as instructed per the IFU. Abbott is developing and will release a software update to prevent the sequence of events described above. This product correction will be included in an upcoming release of the HeartMate Touch software. An Abbott Representative will contact you for a software upgrade beginning Q2 2024. For questions, contact Abbott Technical Support at 1-800-456-1477.

    Distribution

    Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.

    Quantity

    1,560 systems as of 12/8/2023