BEUDAMED
    FDA Enforcement Class III Terminated

    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.

    Recall: Z-1121-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1121-2014
    Event ID
    67490
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    February 6, 2014
    Classification Date
    February 26, 2014
    Termination Date
    June 2, 2014
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565, United States

    Description

    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.

    Reason

    Incorrect master label.

    Code Info

    Lot Number: 50755851

    Distribution

    Nationwide Distribution including TX, ME, IA, PA, OR, and NH.

    Quantity

    191 devices