BEUDAMED
    FDA Recall Terminated

    Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    Recall: Z-2272-2010 · Initiated July 16, 2010

    Recall

    Recall Number
    Z-2272-2010
    Event Number
    56276
    Firm
    Medtronic, Inc.
    FEI Number
    1220452
    Product Code
    MAV
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 16, 2010
    Posted
    August 25, 2010
    Terminated
    June 7, 2011
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565

    Description

    Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    Reason

    Product sterility may be compromised due to breach of package seal integrity.

    Action

    Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.

    Distribution

    Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.

    Quantity

    768 units