BEUDAMED
    FDA Recall Open, Classified

    CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.

    Recall: Z-0218-2024 · Initiated October 4, 2023

    Recall

    Recall Number
    Z-0218-2024
    Event Number
    93141
    Firm
    St. Jude Medical
    FEI Number
    3004936110
    Product Code
    MOM
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 4, 2023
    Posted
    November 3, 2023
    Address
    387 Technology Cir Nw, Ste 500, Atlanta, GA, 30313-2424

    Description

    CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.

    Reason

    Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

    Action

    Abbott notified clinics on about 10/04/2023 via hand delivery of IMPORTANT MEDCIAL DEVICE CORRECTION letter. Clinics were instructed to continue following the IFU and also the supplemental guidance in the letter to continue taking readings as your Health Care Professional has recommended, inspect the Power Connector Plug for damage prior to taking your next reading, if you suspect or identify damage to the power connector plug or any other issues, call Abbott Technical Support, and after the initial inspection, Abbott requests that each Patient Electronics System power connector plug is inspected monthly for damage. Clinics were also notified that patients would be notified of the issue using the addresses listed in the Merlin.net" Patient Care Network; please ensure all patient addresses are up to date. Patients were notified on about 10/18/2023, via IMPORTANT MEDCIAL DEVICE CORRECTION letter. Patients were instructed to continue to take readings as your Health Care Professional has recommended, inspect the power connecter plug for damage prior to taking your next reading, if you suspect or identify damage to the power connector plug contact Abbott Technical Support at 1-844-MYCMEMS (1-844-692-6367) Monday-Friday: 8am-8pm ET, and Abbott requests that each Patient Electronics System power connector plug is inspected monthly for damage.

    Distribution

    Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, KUWAIT, NETHERLANDS, PORTUGAL, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM.

    Quantity

    36,153 units