BEUDAMED
    FDA Enforcement Class II Terminated

    Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.

    Recall: Z-0001-2014 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-0001-2014
    Event ID
    66365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    September 20, 2013
    Classification Date
    October 1, 2013
    Termination Date
    June 10, 2014
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States

    Description

    Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.

    Reason

    MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.

    Code Info

    ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).

    Distribution

    USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.

    Quantity

    20 units (Lot 25052176); 12 units (Lot #25052200)