BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.

    Recall: Z-1570-2014 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1570-2014
    Event ID
    67720
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 14, 2014
    Initiation Date
    February 26, 2014
    Classification Date
    May 8, 2014
    Termination Date
    September 28, 2018
    Address
    7000 Central Ave NE, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.

    Reason

    This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re

    Code Info

    This Medical Device Correction notification affects all SynchroMed II pumps.

    Distribution

    Worldwide Distribution - All states in USA. OUS: List not provided at this time.

    Quantity

    195,198 pumps (146,435 US, 48,763 OUS)