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  • Product Advisories - Abbott Cardiovascular
    These product advisories and communications remain available for review Abbott is notifying customers of a voluntary customer communication for the HeartMate II™ Left Ventricular Assist System (LVAS) and HeartMate 3™ LVAS System Controllers
  • Advisories – Kawartha Cardiology
    ADVISORY Premature Battery Depletion with St Jude Medical ICD and CRT-D devices manufactured before May 23, 2015 Affected models include Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™
  • ABBOTT: Receives FDA Approval for New Heart Rhythm . . . - FDA Reporter
    “The FDA’s approval of Abbott’s Gallant devices enables doctors to provide a more collaborative approach to treatment plans and the increased bond between a patient and provider will lead to better outcomes for all ” The Gallant system received CE Mark for use across Europe earlier this year
  • URGENT MEDICAL DEVICE CORRECTION - Abbott Cardiovascular
    Abbott is informing customers of a rare potential for a Bluetooth (BLE) circuit component issue on a subset of GallantTM, NeutrinoTM NxT, and EntrantTM Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022
  • 2023 - Abbott BLE - Final
    Nature of the Advisory: Abbott has identified an issue with the Bluetooth electrical circuit component of a subset of GallantTM, NeutrinoTM, and EntrantTM Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022
  • Product Advisories | Abbott
    In July 2023, Abbott issued an Urgent Medical Device Correction notice to customers communicating the risk of the inability to exit magnetic resonance imaging (MRI) mode if the Patient Controller has lost the ability to connect or communicate with the IPG while in MRI mode
  • Safety Alert: Abbott - Uregent Medical Device Correction [pdf]
    Summary: Abbott is informing customers of a rare potential for a Bluetooth (BLE) circuit component issue on a subset of GallantTM, NeutrinoTM, and EntrantTM Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022





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