BEUDAMED
    FDA Recall Terminated

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    Recall: Z-2572-2014 · Initiated August 19, 2014

    Recall

    Recall Number
    Z-2572-2014
    Event Number
    69087
    Firm
    St Jude Medical Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 19, 2014
    Posted
    September 3, 2014
    Terminated
    October 8, 2015
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    Reason

    An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.

    Action

    A customer letter dated 8/19/14 was sent to physicians with the affected Ellipse ICDs on 8/20/14. The letter identifies the problems and the actions to be taken. Customers with any questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medicals Technical Services Department.

    Distribution

    Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.

    Quantity

    51,492 units (27,396 units in US)