BEUDAMED
    FDA Recall Terminated

    ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.

    Recall: Z-0267-06 · Initiated October 25, 2005

    Recall

    Recall Number
    Z-0267-06
    Event Number
    34003
    Firm
    ela Medical Llc
    FEI Number
    2182863
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 25, 2005
    Posted
    December 2, 2005
    Terminated
    January 28, 2007
    Address
    2950 Xenium Ln N, Ste 120, Plymouth, MN, 55441-2623

    Description

    ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.

    Reason

    Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.

    Action

    A Dear Doctor letter, dated 10/25/05, was sent to all affected doctors. The letter describes the failures and mentions that pacemaker depend patients implanted with devices manufactured in the first group could require prophylactic replacement.

    Distribution

    Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,

    Quantity

    7